MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2016-07-07 for XCM BIOLOGIC TISSUE MATRIX 30012-31 manufactured by Dsm Biomedical.
[48946820]
Review of the lot history records revealed no deviations that would contribute to suture tear. Given the use of the mesh to bridge a gap in the rectus muscles, excessive forces on the abdominal wall post-operatively may have contributed to the mesh detachment. In addition, presence of bowel contents in the abdominal cavity is known to degrade biologic mesh.
Patient Sequence No: 1, Text Type: N, H10
[48946821]
The patient was female with a significant surgical history consisting of colectomy, stoma, stoma reversal, fistula, and hernia repair. On (b)(6) 2016, another abdominal surgery was performed that involved significant adhesiolysis, fistula debridement and closure, and resection of previously placed mesh. The surgical site was considered to be contaminated. The surgeon was not able to re-approximate the rectus muscles. Therefore, xcm biologic was implanted to bridge the gap in the abdominal wall. Approximately 2 weeks later, the patient presented with wound dehiscence and a small bowel fistula. Upon reoperation, the surgeon reported that the mesh had detached from the right side and was bunched up on the left side of the abdomen. The mesh was described as jelly-like in appearance. The surgeon removed the xcm biologic mesh and implanted vicryl mesh to cover the defect. The patient was still in the hospital one week later, but was no longer septic.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2530154-2016-00010 |
| MDR Report Key | 5775060 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2016-07-07 |
| Date of Report | 2016-07-06 |
| Date of Event | 2016-06-15 |
| Date Mfgr Received | 2016-06-20 |
| Device Manufacturer Date | 2014-07-31 |
| Date Added to Maude | 2016-07-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. FORDE HANSELL |
| Manufacturer Street | 735 PENNSYLVANIA DRIVE |
| Manufacturer City | EXTON PA 19341 |
| Manufacturer Country | US |
| Manufacturer Postal | 19341 |
| Manufacturer Phone | 4847132152 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XCM BIOLOGIC TISSUE MATRIX |
| Generic Name | MESH, SURGICAL, COLLAGEN, LARGE ABDOMINAL WALL DEFECTS |
| Product Code | OXK |
| Date Received | 2016-07-07 |
| Returned To Mfg | 2016-07-01 |
| Model Number | 30012-31 |
| Lot Number | C1026 |
| Device Expiration Date | 2017-06-30 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DSM BIOMEDICAL |
| Manufacturer Address | 735 PENNSYLVANIA DRIVE EXTON PA 19341 US 19341 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-07-07 |