MAUDE Adverse Event Report: 3M HEALTH CARE 3M TRANSPORE WHITE 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	07/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No sample has been received for analysis.3m will continue to monitor.End of report.
Event or Problem Description
Received from(b)(6) : a patient developed a large rash on the cheek with use of 3m transpore white surgical tape was used to affix a tracheal tube after a laparoscopic total hysterectomy, performed under general anesthesia, for uterine fibroids.The rash improved within fifteen minutes after 40 mg of methylprednisolone sodium succinate for injection was administered intravenously.

• Brand Name: 3M TRANSPORE WHITE SURGICAL TAPE
• Common Device Name: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 12320838
• Report Number: 2110898-2021-00048
• Device Sequence Number: 16827626
• Product Code: KGX
• UDI-Device Identifier: 30707387525911
• UDI-Public: 30707387525911
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 08/13/2021

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: 06/14/2023
• Device Model Number: N/A
• Device Catalogue Number: 1534-0
• Device Lot Number: 103158724
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 08/13/2021
• 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: 57 YR