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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Necrosis (1971)
Date of Event	03/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lot #: the product lot number associated with this report was unknown but the customer provided a lot number for the current dressings in stock.The ability of the dressing to absorb wound exudate is based on the materials and construction.The design of the dressing has not changed.No known design changes nor manufacturing changes are known which would affect the absorption properties of the dressing.The lot number that was reported to be in the facility's current stock was reviewed and all in-process and final release requirements were acceptable.A complaint history was reviewed and no trend was seen.
Event or Problem Description
A nurse reported a patient with multiple comorbidities was admitted with an existing sacral pressure wound injury.The nurse reported non-3m dressings were initially applied to the wound.On an unspecified /unknown date, 90647 tegaderm¿ silicone foam border dressing(s) were reportedly applied to the wound by the staff for protection from the patient's diarrhea.The dressing reportedly stayed intact and the patient's diarrhea did not leak into the existing wound.The nurse did not have specific information related to dates of dressing application.The patient allegedly experienced maceration of the peri-wound area following use of the tegaderm¿ silicone foam dressing.The skin reportedly became necrotic and the patient required two debridement procedures.The nurse stated the use of the dressing could not be attributed to the worsening of the wound, but alleged it was a contributing factor.The patient has been discharged to a long-term facility, so the nurse reported limited information was available for this report.

• Brand Name: 3M TEGADERM SILICONE FOAM BORDER DRESSING
• Common Device Name: TEGADERM¿ SILICONE FOAM BORDER DRESSING
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 8607983
• Report Number: 2110898-2019-00076
• Device Sequence Number: 2180551
• Product Code: NAD
• UDI-Device Identifier: 00707387776824
• UDI-Public: 00707387776824
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/14/2019

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 Model Number: N/A
• Device Catalogue Number: 90647
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2019
• Initial Report FDA Received Date: 05/14/2019
• 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: 73 YR