MAUDE Adverse Event Report: DSM BIOMEDICAL XCM BIOLOGIC TISSUE MATRIX; MESH, SURGICAL, COLLAGEN, LG ABD WAL

Catalog Number XM106.2025S

Device Problem Split (2537)

Patient Problem No Information (3190)

Event Date 04/22/2014

Event Type  Injury  

Manufacturer Narrative

The device was repaired and remains in the patient.Photographs were provided for review that demonstrate small tears in the mesh.Although, it cannot be confirmed from the photographs and from the provided information, operational context (method or implantation and patient comorbidities) may have contributed to the event.The device history records for dsm lot number a6366 was reviewed.There were no deviations related to the affected mode, all product met the pre-determined acceptance criteria.There are no like complaints for dsm lot number a6366.The intermediate product lots contain in lot number a6366 have no like failure reported in other upper level lots.

Event Description

The patient has a past medical history that includes multiple abdominal wall revisions.It was reported that the patient presented with toxic megacolon, duodenum fistulae and abdominal fistulae.Colectomy was performed.Xcm biologic was implanted with suture for abdominal wall reconstruction.It was reported that on day 4 post-operative, multiple small tears were observed in the mesh.On day 7 post-operative, the patient returned to the operating theater.The small tears were repaired and an additional xcm biologic mesh was implanted to reinforce the repair.As of the date of this report, the patient's condition has resolved.

• Brand Name: XCM BIOLOGIC TISSUE MATRIX
• Type of Device: MESH, SURGICAL, COLLAGEN, LG ABD WAL
• Manufacturer (Section D): DSM BIOMEDICAL; exton PA
• Manufacturer Contact: forde hansell ; 735 pennsylvania drive; exton, PA 19341 ; 4847132152
• MDR Report Key: 3893601
• MDR Text Key: 19390529
• Report Number: 2530154-2014-00005
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K091499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Catalogue Number: XM106.2025S
• Device Lot Number: A6366
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2012
• 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): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 80