MAUDE Adverse Event Report: BAYER HEALTHCARE LLC DR SCHOLLS FREEZE AWAY DUAL ACTION; UNIT, CRYOSURGICAL, ACCESSORIES

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vomiting (2144)
Date of Event	11/18/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
This spontaneous case was reported by another health professional and describes the occurrence of haematemesis ("(b)(6) ate this and had bloody vomit") in a (b)(6) male patient who received dr scholls freeze away dual action cutaneous spray.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: accidental device ingestion by a child "(b)(6) infant ingest this" on (b)(6) 2018.On (b)(6) 2018, the patient experienced haematemesis (seriousness criterion medically significant) and dyspnoea ("(b)(6) ate this and had difficulty breathing").It was unknown whether any action was taken with dr scholls freeze away dual action.At the time of the report, the haematemesis and dyspnoea outcome was unknown.The reporter provided no causality assessment for dyspnoea and haematemesis with dr scholls freeze away dual action.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be (b)(6).This (b)(6) patient ingested salicylic acid, dimethyl ether, propane and experienced haematemesis on the next day.Only haematemesis is unlisted according to salicylic acid, dimethyl ether, propane reference safety information.Taking into consideration the close temporal relationship between accidental ingestion (of a topical product) and the event, causal or contributory role of salicylic acid, dimethyl ether, propane to haematemesis cannot be excluded.This case was regarded as incident.

• Brand Name: DR SCHOLLS FREEZE AWAY DUAL ACTION
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): BAYER HEALTHCARE LLC; 4207 michigan avenue rd ne; cleveland TN 37123
• MDR Report Key: 8095230
• Report Number: 1031623-2018-00004
• Device Sequence Number: 11259487
• Product Code: GEH
• UDI-Device Identifier: 00311017405307
• UDI-Public: 00311017405307
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K052259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 11/21/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 14 MO
• Patient Weight: 9