MAUDE Adverse Event Report: DSM BIOMEDICAL MESO BIOMATRIX ACELLULAR PERITONEUM MATRIX; SURGICAL MESH

Model Number	30063-04
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Erythema (1840)
Date of Event	09/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a female patient had bilateral breast implant exchange with meso biomatrix mesh placement for capsular contracture and asymmetry.Approximately 4 months post-operative, the patient had swelling, redness and impending implant extrusion in the left breast.Cultures were taken and results were negative.The breast implant and meso biomatrix were subsequently explanted from the left breast.Approximately, 3 months later, the breast implant was replaced.
Additional Manufacturer Narrative
The device was not returned for evaluation.Therefore, the investigation was limited to review of the clinical information, complaint and manufacturing records.No deviations or non-conformances were identified in the lot history.No complaint or adverse event trends were identified.The available clinical information was insufficient to identify the cause of the adverse events.Therefore, no root cause could be determined.
Additional Manufacturer Narrative
The device was not returned for evaluation.Therefore, the investigation was limited to review of the clinical information, complaint and manufacturing records.No deviations or non-conformances were identified in the lot history.No complaint or adverse event trends were identified.The available clinical information was insufficient to identify the cause of the adverse events.Therefore, no root cause could be determined.
Event or Problem Description
It was reported that a female patient had bilateral breast implant exchange with meso biomatrix mesh placement for capsular contracture and asymmetry.Approximately 4 months post-operative, the patient had swelling, redness and impending implant extrusion in the left breast.Cultures were taken and results were negative.The breast implant and meso biomatrix were subsequently explanted from the left breast.Approximately, 3 months later, the breast implant was replaced.

• Brand Name: MESO BIOMATRIX ACELLULAR PERITONEUM MATRIX
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DSM BIOMEDICAL; 735 pennsylvania drive; exton PA 19341
• Manufacturer (Section G): DSM BIOMEDICAL; 735 pennsylvania drive; exton PA 19341
• Manufacturer Contact: forde hansell ; 735 pennsylvania drive; exton, PA 19341 ; 4847132152
• MDR Report Key: 13577828
• Report Number: 2530154-2022-00001
• Device Sequence Number: 5618672
• Product Code: FTM
• UDI-Device Identifier: 00812337025331
• UDI-Public: 00812337025331
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K094061
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/21/2022

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: 03/28/2022
• Device Model Number: 30063-04
• Device Catalogue Number: 910816
• Device Lot Number: 7005080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SMOOTH ROUND HIGHLY COHESIVE BREAST IMPLANT
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 54 KG