MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. UNISOLVE ADHESIVE REMOVER WIPES; SOLVENT, ADHESIVE TAPE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Caustic/Chemical Burns (2549)

Event Date 03/01/2021

Event Type  Injury  

Event Description

I used the uni-solve to wipe off the sticky substance that was left from my injection site for my sensor.The uni-solve wipe left me with a chemical burn on my stomach.

• Brand Name: UNISOLVE ADHESIVE REMOVER WIPES
• Type of Device: SOLVENT, ADHESIVE TAPE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.
• MDR Report Key: 11505913
• MDR Text Key: 240666246
• Report Number: MW5100030
• Device Sequence Number: 1
• 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: 03/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 88