MAUDE Adverse Event Report: 3M HEALTH CARE NEXCARE(TM) MAX HOLD WATERPROOF BANDAGES; TAPE AND BANDAGE, ADHESIVE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Rash (2033); Skin Inflammation/ Irritation (4545)
Date of Event	10/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product has a 5 year shelf life.No lot # was provided, therefore device manufacture date is unknown.No sample has been received for analysis.The 2-year complaint history was reviewed for the product's global sales code (gsc) of sxj and reported failure.No trends were observed.3m will continue to monitor.Test results confirm the biocompatibility of nexcare¿ waterproof bandages 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.End of report.
Event or Problem Description
A female customer (age unspecified) alleged the nexcare clear waterproof bandages caused rash to her back (exact location unspecified).The customer stated she had a surgical procedure done on her back on (b)(6) 2020, and she was instructed by the doctor to cleanse the surgical area (customer did not specify what was used to clean area), apply vaseline and cover with bandage.The customer stated she changed the bandage every night.The customer alleged she noticed the rash 72 hours after applying the bandage.She stated the first couple of days she used the bandage, she wasn't sure if it was the bandage that was irritating her or if it was the surgical wound.The customer reported she instructed her husband to use rubbing alcohol and lotion to soothe the alleged injury area.She alleged the rash is about 6 by 6 inches beyond the area where the bandage touched her skin.The customer alleged the doctor prescribed mometasone 1% for the alleged rash.The customer reported she's allergic to latex, codeine, iodine and salsa rugs.No medical history reported.
Additional Manufacturer Narrative
Additional information was received from the reporter: updated information for brand name.Updated information for catalog number and unique identifier (udi) number.

• Brand Name: NEXCARE(TM) MAX HOLD WATERPROOF BANDAGES
• Common Device Name: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 10905161
• Report Number: 2110898-2020-00060
• Device Sequence Number: 2713464
• Product Code: KGX
• UDI-Device Identifier: 00051131997608
• UDI-Public: 051131997608
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2021

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
• Operator of Device: Other
• Device Model Number: N/A
• Device Catalogue Number: MHW-60
• Device Lot Number: N/A
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 02/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other