MAUDE Adverse Event Report: 3M HEALTH CARE 3M MICROPORE SURGICAL TAPE; 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	Skin Burning Sensation (4540); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)
Date of Event	06/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2, a4: not provided.H10: a sample has been returned and a lot number was provided; analysis is ongoing.End of report.
Event or Problem Description
Skin redness, induration, swelling, itchiness, and a burning sensation developed eight days after a breast reduction surgery at the perimeter of.Where 3m micropore surgical tape was applied on both breasts.Several layers of tape were applied over sutured incisions.Skin preparation for the surgery included chlorhexidine gluconate.At the end of the procedure, the area was cleansed with a hydrogen peroxide/saline mixture and alcohol was applied to the incisions and allowed to dry prior to tape application.The tape was applied one time and was not difficult to remove.Topical hydrocortisone was applied.On post-operative day eleven, temovate(r) (clobetasol propionate) topical was prescribed, after which the symptoms improved.The reporter informed that they have used this tape product for several years without issue.The reporter felt that the newer boxes of tape had a strong glue/chemical odor whereas older boxes with a black side did not.
Additional Manufacturer Narrative
H10: a sample was returned for analysis and a lot number was provided.No issues were identified in the production history or with the sample returned.It is not possible to definitively determine the root cause.3m will continue to monitor.End of report.

• Brand Name: 3M MICROPORE SURGICAL TAPE
• Common Device Name: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M DEUTSCHLAND GMBH WERK KAMEN; edisonstrasse 6; 59174 kamen; kamen, deu, ; GM
• Manufacturer Contact: nadia battah ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144-1000 ; 6514612670
• MDR Report Key: 17414445
• Report Number: 2110898-2023-00072
• Device Sequence Number: 6983257
• Product Code: KGX
• UDI-Device Identifier: 04064035099688
• UDI-Public: 04064035099688
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/22/2025
• Device Model Number: N/A
• Device Catalogue Number: 1530-1
• Device Lot Number: 105126291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2023
• Supplement Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 07/28/2023
• Supplement Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian