MAUDE Adverse Event Report: 3M HEALTH CARE NEXCARE¿ STRONG HOLD PAIN FREE REMOVAL BANDAGES; TAPE AND BANDAGE, ADHESIVE

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

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

Event Date 12/11/2022

Event Type  Injury  

Event Description

A female customer (age unspecified) reported an incident regarding the nexcare¿ strong hold pain free removal bandages.On an unspecified date, a mole was removed from her abdomen.On (b)(6) 2022, she applied the nexcare bandage on her abdomen covering the incision.The bandage was in place for about four to five hours.While the bandage was in place, the area was itchy.After she removed the bandage, she allegedly noticed a red line where the bandage pad was placed.The area was allegedly blotchy and itchy.She alleged the redness spread roughly 5"x10" from where the pad touched her skin.The redness was allegedly only on the right side of her abdomen.On unspecified date, she sent the pictures of the alleged injury to her dermatologist.The dermatologist prescribed an unspecified steroid cream.She applied the cream twice a daily and placed ice on the area.On an unspecified date, the inflammation started to decrease.Her doctor said that it will be a while before the alleged injury completely resolved.On (b)(6) 2023, the customer alleged the outline of the pad and inflamed itchy areas on her skin were still visible after three weeks of using the prescribed steroid cream twice daily.She is allergic to penicillin.No medical history reported.

Manufacturer Narrative

Expiration date: product has a 3 year shelf life.No sample has been returned to 3m for evaluation.Root cause of reported issue could not be established.End of report.

• Brand Name: NEXCARE¿ STRONG HOLD PAIN FREE REMOVAL BANDAGES
• 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; 905 adams street se; hutchinson MN 55350
• Manufacturer Contact: bryan becker ; 2510 conway avenue; st. paul, MN 55144 ; 6517375578
• MDR Report Key: 16142183
• MDR Text Key: 307154567
• Report Number: 2110898-2023-00003
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 00051131193581
• UDI-Public: 051131193581
• 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: 01/11/2023

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
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: SSB-20A
• Device Lot Number: 21179M
• Initial Date Manufacturer Received: 12/14/2022
• Initial Date FDA Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female