MAUDE Adverse Event Report: DSM BIOMEDICAL MESO BIOMATRIX ACELLULAR PERITONEUM MATRIX; MESH, SURGICAL, COLLAGEN, PLASTIC AND RECONSTRUCTIVE SURGERY

Model Number 30055-06

Device Problem Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Tissue Damage (2104)

Event Date 12/04/2015

Event Type  Injury  

Manufacturer Narrative

Review of the device history records does not have deviations that would contribute to the reported complications.The product met all pre-determined acceptance criteria.Review of sterilization records indicate the product was processed in accordance with product requirements and met all pre-determined acceptance criteria for sterility.The cause of the complication can not be determined from the provided information or the manufacturing records.Device discarded at hospital.

Event Description

A female patient had bilateral mastectomy followed by immediate single stage, bilateral breast reconstruction with 320cc textured, silicone gel breast implants.Meso biomatrix was implanted in each breast.Approximately 2 months later, the left breast was observed to have 'thin skin.' she was started on intravenous antibiotics and the thin skin was excised and closed.On the following day, the wound was reportedly healing.However, 4 days later, the left breast wound dehisced and the implant was visible.The right breast also had an infected appearance.The patient decided to have both implants removed.So that same day, the implants and meso biomatrix were removed bilaterally.At the time of explantation, the surgeon noted the meso biomatrix to be thin and barely recognizable.Intravenous antibiotics were continued for 24 hours, followed by oral antibiotics for 5 days.The dehiscence were reported to have resolved.

• Brand Name: MESO BIOMATRIX ACELLULAR PERITONEUM MATRIX
• Type of Device: MESH, SURGICAL, COLLAGEN, PLASTIC AND RECONSTRUCTIVE SURGERY
• Manufacturer (Section D): DSM BIOMEDICAL; 735 pennsylvania drive; exton PA 19341
• Manufacturer Contact: forde hansell ; 735 pennsylvania drive; exton, PA 19341 ; 4847132152
• MDR Report Key: 5470915
• MDR Text Key: 39416367
• Report Number: 2530154-2016-00002
• Device Sequence Number: 1
• Product Code: OXH
• 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: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2015
• Device Model Number: 30055-06
• Device Lot Number: C0767
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR