MAUDE Adverse Event Report: DSM BIOMEDICAL XCM BIOLOGIC TISSUE MATRIX; MESH, SURGICAL, COLLAGEN, LARGE ABDOMINAL WALL DEFECTS

Device Problem Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/14/2015

Event Type  Injury  

Manufacturer Narrative

The mesh tears were repaired during the planned second stage procedure.Therefore, the device remains in the patient and will not be returned for evaluation.No photographs of the device have been provided for evaluation.No model number and lot number have been provided.Therefore, no device evaluation or manufacturing record review could be performed.In addition, no information has been provided about the patient's demographics, method of mesh implantation or concomitant medical products used.Multiple attempts have been made to obtain additional clinical information.If additional information is provided, it will be reported in a follow-up mdr.

Event Description

It was reported that xcm biologic was implanted in a patient as part of a complex, multi-stage abdominal surgical procedure that involved colon resection and repair of multiple fistulas.At the end of the procedure, the surgical wound was left open due to the complexity of the case and wound closure was planned for the following day.During the second stage of the procedure, the surgeon observed 'some small tears' in the mesh.The tears were repaired during the second stage procedure and the surgical wound was closed.No clinical consequences were observed.

• Brand Name: XCM BIOLOGIC TISSUE MATRIX
• Type of Device: MESH, SURGICAL, COLLAGEN, LARGE ABDOMINAL WALL DEFECTS
• 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: 5231292
• MDR Text Key: 31453298
• Report Number: 2530154-2015-00004
• Device Sequence Number: 1
• Product Code: OXK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2015
• 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