Be Natural Callus Eliminator liquid drugs

The reports, as CPSC published them

1. Hospital admission

   Made Oct 19, 2015 · , sent to the company Oct 29, 2015 · , published by CPSC Nov 13, 2015

   The product, in the report: This product is designed to remove foot calluses. The active ingredient appears to be Potassium Hydroxide. Per the MSD sheet it has a Potassium Hydroxide concentration of less than 20% and pH of 13-14. I do not know the actual KOH concentration by volume.

   On 6/9/2015 a 12 month old female ingested a small volume of “Be Natural Callus Eliminator” manufactured by ProLinc in the family home and developed a distal esophageal caustic stricture that has required 4 endoscopic stricture dilations. The active ingredient in the product is Potassium Hydroxide with a concentration of less than 20% and pH of 13-14 per the MSD sheet (according to poison control office). The family reports that the over the counter product was on a living room coffee table with the cap on. The cap is a twist non-safety cap. The child climbed onto the couch to get it and the child was biting the cap when it came off. The amount of possible ingestion was unclear but estimated to be less than 1 teaspoon. The child became fussy. The family called the Northern New England Poison Control Center 207-662-4720 and was told to be seen at a local emergency department. The child initially calmed down and fell asleep at home but awoke crying. The child was seen in the early morning on 6/10/15 at the Central Maine Medical Center ED. There were no visible oral burns and the child was discharged, able to take PO. The patient developed progressive solid food dysphagia over the course of approximately the next 10 days. The child had an Upper GI Contrast study performed locally on 6/22/15 in Maine which demonstrated a distal esophageal stricture. The child developed progressive dysphagia and on 7/6/15 she presented to the Boston Children’s Hospital ED with inability to tolerate purees and even inability to tolerate liquids ingested quickly with vomiting. She was admitted. I performed an upper endoscopy on 7/7/2015 which demonstrated a tight distal esophageal stricture with inner diameter of 2mm. The stricture was located 5mm proximal to the gastroesophageal junction as was consistent with a caustic stricture. Proximal retained esophageal food impaction was removed and the stricture was dilated to 8mm. She was discharged on 7/7/2015. I have since performed 3 additional outpatient esophageal dilations on this patient on: 7/22/15, 8/14/2015, and 10/15/2015 with progressive improvement in dysphagia.

   I contacted the Northern New England Poison Control Center 207-662-4720 on 10/16/2015 again and spoke with [REDACTED] there. I was informed that they have had an additional case of caustic ingestion with this same Potassium Hydroxide based Callus Remover. The brand was reported to be different but the manufacturer was the same. [REDACTED]informed me that she spoke with a representative from the manufacturer following both ingestion cases. I was informed that the second case involved a 14 month old girl who ingested the product at home and had an upper endoscopy performed which showed: circumferential moderate to severe burns to the upper third of the esophagus. Exposure was on 8/15 or 8/16/2015.

   I am unaware if there have been additional cases of caustic ingestion with this product nationally or internationally. There is no prior literature on caustic ingestion with this specifict product that I can find. I am concened because it appears to me that this product previously had been accessible mainly in salons or podiatrist offices but is now readily available to consumers over the counter (i.e. on amazon.com). The lack of very obvious ingestion warning signs on the bottle and the lack of a safety cap are additional major concerns.

   I will try to obtain contact information for the GI provider of this second case and request that they also report their case to CPSC.

   Please do not hesitate to contact me for further information.

   Where

   Winthrop, Maine: Home/Apartment/Condominium

   Who was involved

   Age 1, Female

   The reporter’s relation to them

   My Client, Patient, Student, Etc. (professional relationship)

   As this report names them

   Brand Be Natural Callus Eliminator, made or sold by American International Industries

   How badly, in CPSC’s words

   Injury, Hospital Admission

CPSC’s disclaimer

Sources