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); Rash (2033); Skin Irritation (2076)
Date of Event	05/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This product has a 5-year shelf life.The device has been not returned for evaluation, though requested by 3m.Complaint history was reviewed for the last 24-month period for the failure code, product's global sales code of sxj, and reported lot 19016m.No statistical trend was observed.3m will continue to monitor.End of report.
Event or Problem Description
The mother of a (b)(6) female reported her daughter applied four of the referenced bandages to her left leg, each application, to cover a rash on the inside thigh.Skin preparation details were not specified.Date(s) and duration of wear was not specified.The mother reported her daughter changed the bandages after showering.Total number of applications was unknown.The mother alleged her daughter had a red, bumpy and "blistery" skin reaction to the bandages.The reaction occurred where the bandage adhesive was in contact with the skin.The mother reported her daughter has no known allergies.The daughter visited a doctor on approximately (b)(6) 2019.The mother reported the doctor stated her daughter had a an "allergic reaction" to the bandages.An unspecified topical medication was prescribed.The daughter discontinued use of the bandages per the doctor's recommendation.The mother reported the affected area was improving with the use of the prescribed medication.
Additional Manufacturer Narrative
Updated method, results, and conclusion codes based off analysis findings.The device was received and evaluated.A visual review found no notable damage, defects, or foreign matter.Complaint history was reviewed for the last 24-month period for the failure code, product's global sales code of sxj, and reported lot 19016m.No statistical trend was observed.3m will continue to monitor.

• 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: 8754458
• Report Number: 2110898-2019-00085
• Device Sequence Number: 19254890
• Product Code: KGX
• UDI-Device Identifier: 00051131212787
• UDI-Public: 00051131212787
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2019

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
• Device Lot Number: 19016M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2019
• Supplement Date Received by Manufacturer: 06/06/2019
• Initial Report FDA Received Date: 07/02/2019
• Supplement Report FDA Received Date: 08/22/2019
• 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
• Patient Age: 20 YR