MAUDE Adverse Event Report: 3M HEALTH CARE 3M MICROPORE SURGICAL TAPE; 3M¿ MICROPORE¿ SURGICAL TAPE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Skin Inflammation/ Irritation (4545)
Date of Event	04/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier , weight: not specified.A sample of 3m micropore surgical tape was not received.Production records were reviewed for the reported lot and no issues were indicated.
Event or Problem Description
Received from (b)(6): a patient had an operation due to underarm odor and 3m¿ micropore¿ surgical tape was applied after the procedure.About 30 minutes later, skin redness, itchiness, swelling and a few blisters resulted in the tape application area.The skin was wiped with alcohol, dexamethasone was given intravenously and applied topically to the skin, and the area was no longer covered with 3m tapes and elastic bandages.After treatment, the symptoms were alleviated.

• Brand Name: 3M MICROPORE SURGICAL TAPE
• Common Device Name: 3M¿ MICROPORE¿ SURGICAL TAPE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 11970320
• Report Number: 2110898-2021-00035
• Device Sequence Number: 4543304
• Product Code: KGX
• UDI-Device Identifier: 30707387066018
• UDI-Public: 30707387066018
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/09/2021

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: Health Professional
• Device Expiration Date: 07/06/2025
• Device Model Number: N/A
• Device Catalogue Number: 1533-1
• Device Lot Number: 339L3J
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 06/09/2021
• 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: Required Intervention
• Patient Age: 31 YR