MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNI-SOLVE ADHESIVE REMOVER WIPES; SOLVENT, ADHESIVE TAPE

Lot Number 7720

Device Problem Product Quality Problem (1506)

Patient Problems Rash (2033); Reaction (2414); Caustic/Chemical Burns (2549)

Event Date 07/08/2020

Event Type  No Answer Provided  

Event Description

Severe rash/chemical burn.Have a poweline catheter implant in my chest that requires dressings.I have adhesive allergies that were previously managed by using skin prep.The supply company sent smith&nephew brand adhesive remover and smith&nephew brand skin prep.However, the skin prep is in orange and green packaging while the adhesive remover is orange and dark orange.This resulted in us mixing up the two and using adhesive remover without using skin prep, resulting in a severe allergic reaction that blistered and was essentially a chemical burn.Used to prevent skin allergy reactions with dressings.Intended remove residual adhesive, but was mistaken for skin.

• Brand Name: UNI-SOLVE ADHESIVE REMOVER WIPES
• Type of Device: SOLVENT, ADHESIVE TAPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.
• MDR Report Key: 10355978
• MDR Text Key: 201688020
• Report Number: MW5095847
• Device Sequence Number: 2
• Product Code: KOX
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/30/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 7720
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/31/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25 YR
• Patient Weight: 99