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 Edema (1820); Erythema (1840); Unspecified Infection (1930); Pain (1994); Swelling (2091); Organ Dehiscence (2502)

Event Date 01/18/2016

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

The patient presented with capsular contracture of the left breast following a prior breast reconstruction.On (b)(6) 2015, the left breast was revised with capsulectomy, meso biomatrix implantation and implantation of a new breast implant (size and manufacturer not reported).Approximately 6 months later, she presented with a clinically infected left breast.It was described as diffuse redness and pain over the entire breast with some fluid surrounding the implant and a little edema.She had no fever.She was admitted to the hospital and started on intravenous antibiotics.After 2 days of iv antibiotics the infection worsened with dehiscence of the surgical scar.Therefore, the breast implant and meso biomatrix were surgically removed.Prior to removal, meso biomatrix was observed to be integrated at the periphery of the device but not in the center.The infection and 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: 5471832
• MDR Text Key: 39424978
• Report Number: 2530154-2016-00005
• Device Sequence Number: 1
• Product Code: OXH
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 02/12/2016
• 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: 74 YR