MAUDE Adverse Event Report: 3M HEALTH CARE 3M TEGADERM DRESSING; 3M¿ TEGADERM¿

Model Number	9543HP
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Erythema (1840); Blister (4537)
Date of Event	03/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information: unknown.Lot number and expiration date is unknown.Device manufacture date unknown.Device has been discarded; complaint was received without a model number.3m¿ tegaderm¿ transparent film dressing frame style 9543hp is being used.3m¿ will continue to monitor.
Event or Problem Description
A male patient reported undergoing robotic hernia surgery on (b)(6) 2021.Three incisions were made on his abdomen and covered with a 3m¿ tegaderm¿ dressing.The patient removed the dressing 48 hours later and alleged skin redness and blisters in five areas.No medical interventions were required.Currently the patient's skin is healed and reports five areas of scar like symptoms.

• Brand Name: 3M TEGADERM DRESSING
• Common Device Name: 3M¿ TEGADERM¿
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 11843331
• Report Number: 2110898-2021-00033
• Device Sequence Number: 11755331
• Product Code: NAD
• UDI-Device Identifier: 00707387446406
• UDI-Public: 00707387446406
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/18/2021

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: No Information
• Device Model Number: 9543HP
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 05/18/2021
• 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: Disability