MAUDE Adverse Event Report: 3M HEALTH CARE 3M TRANSPORE 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	Rash (2033); Local Reaction (2035)
Date of Event	11/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient developed a rash described as the size of the palm of a hand after use of 3m transpore surgical tape.The tape was applied with overnight wear to secure a catheter.Fucidin(r) 2% cream and taro-clobetasol 0.05% cream were prescribed and applied topically twice a day and the rash resolved.
Additional Manufacturer Narrative
Lot number was not provided; therefore, unable to determine expiration date and date of manufacture.A sample was not available for return for analysis and no lot number was provided.3m will continue to monitor.End of report.

• Brand Name: 3M TRANSPORE 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 BROOKINGS; 601 22nd avenue south; brookings SD 57006
• Manufacturer Contact: dianne gibbs ; 3m center building 275-5w-06; st. paul, MN 55144 ; 6517379117
• MDR Report Key: 12962165
• Report Number: 2110898-2021-00073
• Device Sequence Number: 13901267
• Product Code: KGX
• UDI-Device Identifier: 30707387065950
• UDI-Public: 30707387065950
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Consumer,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/07/2021

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: 1517-1
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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