MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ NEXCARE¿ 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	Erythema (1840); Skin Irritation (2076)
Date of Event	02/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age or date of birth, weight, ethnicity, race: this information was not provided.Lot #, expiration date: lot # provided was 186935rev-01.This is not a valid lot code; therefore, expire date unknown.Clear waterproof bandages have a 5 years shelf life.Reporter: initial reporter's full physical address and email address was not provided.Occupation: initial reporter's occupation was not specified.Manufacture date: a valid lot # was not provided; therefore, manufacture date is unknown.The device has been not returned for evaluation, though requested by 3m.Complaint history for the last 24 months was reviewed for the defined failure code for the product's global sales code (gsc) of sxj.No trends were observed.The product will be evaluated and a follow up report will be submitted if product is received.
Event or Problem Description
A female customer (age not specified) applied the referenced bandages to her left cheek to cover a surgery wound.The woman applied the bandages to cover the partially healed wound while going into water.The bandages were used for a couple of weeks.Bandage adhesive placement was not rotated during application.No ointment or creams were being applied to the wound site.On (b)(6) 2019, the woman alleged noticing her skin underneath the bandage was bright red upon removal.She reported the bandage was removed gently.The reddened skin was reported to be in the shape of the bandage adhesive.No bumps were present.No known allergies were specified.The woman discontinued use of the bandages.The woman alleged the skin surrounding the bandage application area developed a bright red rash which spread.She consulted a dermatologist on an unspecified date.The dermatologist recommended hydrocortisone 2.5% topical be applied over the affected area.On (b)(6) 2019, the woman reported the affected area was clearing up with one day remaining on prescribed hydrocortisone.
Additional Manufacturer Narrative
The device was returned for evaluation.Method, results, and conclusion codes updated.The device was returned for evaluation.A review of the returned bandage found no visible foreign matter, effects of damage to bandage or cold seal.Complaint history for the last 24 months was reviewed for the defined failure code for the product's global sales code (gsc) of sxj.No trends were observed.

• Brand Name: 3M¿ NEXCARE¿ WATERPROOF BANDAGES
• Common Device Name: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway avenue; st. paul MN 55144
• MDR Report Key: 8409476
• Report Number: 2110898-2019-00034
• Device Sequence Number: 13946988
• Product Code: KGX
• UDI-Device Identifier: 00051131212787
• UDI-Public: 00051131212787
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2019

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: 432-50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 03/11/2019
• Supplement Report FDA Received Date: 04/02/2019
• 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; Required Intervention