MAUDE Adverse Event Report: TAPE ++ ADHESIVE REMOVER; SOLVENT, ADHESIVE TAPE

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Event Description

Call from patient regarding adhesive removers we had sent him in the past.He had some issues with having a rash after using them, but was unsure of the exact product number.Sending 3 different types of adhesive removers in hopes that 1 of them works for him.Reported to (b)(6)/caremark by pt/caregiver.

• Brand Name: TAPE ++ ADHESIVE REMOVER
• Type of Device: SOLVENT, ADHESIVE TAPE
• MDR Report Key: 14111840
• MDR Text Key: 289348737
• Report Number: MW5108991
• Device Sequence Number: 1
• Product Code: KOX
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Sex: Male