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

Model Number 30055-05

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Pain (1994); Seroma (2069)

Event Type  Injury  

Manufacturer Narrative

Review of the device history records revealed no 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.Multiple attempts have been made to obtain additional clinical information.If additional information is provided, it will be reported in a follow-up report.Device not returned.

Event Description

It was reported that the patient had meso biomatrix implanted as of a breast reconstruction surgical procedure.At an unknown time post-operative, seroma, breast erythema and pain were reported.The meso biomatrix was subsequently explanted.It was reported that the mesh had a 'jelly-like' in appearance at the time of explantation and was not incorporated with the subcutaneous tissue.No additional information is available as of the date of this initial report.

• 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: 5541616
• MDR Text Key: 41669126
• Report Number: 2530154-2016-00009
• Device Sequence Number: 1
• Product Code: OXH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K094061
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2016
• Device Model Number: 30055-05
• Device Lot Number: C5183
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2015
• 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