MAUDE Adverse Event Report: 3M HEALTH CARE NEXCARE FLEXIBLE CLEAR TAPE; TAPE AND BANDAGE, ADHESIVE

Catalog Number 779

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Rash (2033); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Manufacturer Narrative

Date of event: information was not provided.Device lot number was not provided.Lot number was not provided.Therefore, manufacture date unknown.No sample has been received for analysis.The 2-year complaint history was reviewed for the product's global sales code (gsc) of szp and reported failure.No trends were observed.3m will continue to monitor.Test results confirm the biocompatibility of nexcare¿ flexible clear tape for their intended use.In addition to performing clinical studies, 3m¿ monitors its medical devices with manufacturing controls, including in-process specifications, release specifications and testing.

Event Description

A female customer (age unspecified) reported an incident regarding the nexcare¿ flexible clear first aid tape.On an unspecified date, the bandage was applied over another brand of bandage covering a draining sore (type of drainage was not reported) on her ankle (exact location was reported).A couple of days later, she allegedly broke out in a rash on her stomach, chin, arms and the back of her ears.She alleged her lower arm was also slightly swollen.On an unspecified date, the doctor prescribed triamcinolone acetonide ointment usp 0.1% for the rash.No allergies, medical history or intervention reported.

• Brand Name: NEXCARE FLEXIBLE CLEAR TAPE
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M COMPANY; 601 22nd ave south; brookings SD 57006
• Manufacturer Contact: bryan becker ; 2510 conway avenue; st. paul, MN 55144 ; 6517375578
• MDR Report Key: 12577078
• MDR Text Key: 274755923
• Report Number: 2110898-2021-00061
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 00051131669949
• UDI-Public: 00051131669949
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/05/2021

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
• Device Operator: Other
• Device Catalogue Number: 779
• Initial Date Manufacturer Received: 07/07/2021
• Initial Date FDA Received: 10/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention