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 Erythema (1840); Unspecified Infection (1930)

Event Date 10/23/2015

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.

Event Description

A female patient had prior bilateral mastectomy followed by tissue expander implantation.On (b)(6) 2015, she had the tissue expanders replaced with 410cc textured, silicone gel breast implants bilaterally.Meso biomatrix was also implanted in each breast.Approximately 2 weeks later, redness was observed on the medial side of the left breast.It was described as shiny and warm.She had no clinical signs of infection.She was admitted to the hospital and started on intravenous antibiotics, which continued for 5 days.The symptoms lessened while in the hospital.She was discharged on oral antibiotics for 6 weeks.At the end of the 6 week course of antibiotics, there were no signs of infection.

• 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: 5470924
• MDR Text Key: 39397365
• Report Number: 2530154-2016-00004
• 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?: No
• 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
• Treatment: VICRYL SUTURE
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR