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

Model Number 30063-04

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Erythema (1840)

Event Date 10/19/2021

Event Type  Injury  

Event Description

It was reported that a female patient had bilateral breast implant exchange with meso biomatrix mesh placement for capsular contracture and asymmetry.Approximately 5 months post-operative, the patient had swelling, redness and impending implant extrusion in the right breast.The breast implant and meso biomatrix were subsequently explanted from the right breast.Approximately, 2 months later, the breast implant was replaced.

Manufacturer Narrative

The device was not returned for evaluation.Therefore, the investigation was limited to review of the clinical information, complaint records 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.

• Brand Name: MESO BIOMATRIX ACELLULAR PERITONEUM MATRIX
• Type of Device: 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: 13577845
• MDR Text Key: 285936961
• Report Number: 2530154-2022-00002
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 00812337025331
• UDI-Public: 00812337025331
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K094061
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SMOOTH ROUND HIGHLY COHESIVE BREAST IMPLANT
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 54 KG