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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Local Reaction (2035); Blister (4537); Skin Inflammation/ Irritation (4545)
Date of Event	02/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lot number not provided therefore unable to determine expiration date.Lot number not provided therefore unable to determine manufacture date.No sample has been received for analysis.The 2-year complaint history was reviewed for the product's global sales code mgs.No trends were observed.3m will continue to monitor.
Event or Problem Description
A female customer alleged that her 10 years old daughter had a severe allergic reaction to the 3m¿ transpore¿ surgical tape.Her daughter had a wart infection.She applied an over the counter wart medicine (medication unspecified) to the area before she applied the transpore tape.The tape was applied to her left inner thigh.She used the bandage for 3 consecutive days.The tape was in place for about 16-24 hours and was changed daily.She first noticed the alleged injury on (b)(6) 2021.She alleged the area was red, bubbly and looked like a blister.She treated the areas with a steroid cream (triamcinolone acetonite ointment) that was prescribed by the doctor.The alleged injury is resolving.She reported that her daughter is allergic to hay fever and had a past allergic reaction to latex tape after routine infant immunization.No medical history reported.

• Brand Name: 3M TRANSPORE SURGICAL TAPE
• Common Device Name: TRANSPORE¿ TAPE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 11530090
• Report Number: 2110898-2021-00020
• Device Sequence Number: 5513113
• Product Code: KGX
• UDI-Device Identifier: 30707387065950
• UDI-Public: 30707387065950
• 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
• Report Date (Section B): 03/19/2021

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 1527-1
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 03/19/2021
• 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; Required Intervention
• Patient Age: 10 YR