MAUDE Adverse Event Report: 3M COMPANY 3M STERI-STRIP ANTIMICROBIAL SKIN CLOS; TAPE AND BANDAGE, ADHESIVE

Patient Problem Diaphoresis (2452)

Event Type  Injury  

Event Description

It was reported that when implanted, they were really sweaty (they reported relevant medical history that they were menopausal and would sweat all night) and so the steri-strips weren't sticking/wouldn't work; their spouse had to fix the incision.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: 3M STERI-STRIP ANTIMICROBIAL SKIN CLOS
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): 3M COMPANY
• MDR Report Key: 17574950
• MDR Text Key: 321572719
• Report Number: MW5144742
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/15/2023

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/17/2023
• Patient Sequence Number: 1