MAUDE Adverse Event Report: 3M MICROPORE; TAPE AND BANDAGE, ADHESIVE

Device Problem Insufficient Information (3190)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Event Description

This afternoon, we spoke with (b)(6) and walked him through the order process (he's from our medium-touch group).During our call, he mentioned how the tape on his prescription gave bim a terrible rash and that be had to go to the hospital (over easter).I believe another patient (in hick or home) also bad a bad reaction to the tape.Ls there someone we can forward this info too so that they can look into alternative tape solutions? he actually included two pictures of the tape he got on amazon that works much better.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: MICROPORE
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): 3M
• MDR Report Key: 17529954
• MDR Text Key: 321053888
• Report Number: MW5136876
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1