MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,user faci report with the FDA on 2018-01-25 for XCM BIOLOGIC TISSUE MATRIX 30012-31 manufactured by Dsm Biomedical.
[98278732]
Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[98278733]
It was reported that the surgeon used an xcm mesh in a trauma patient to reinforce the abdominal wall. After 5 days, the mesh presented with a fetid smell, with parts of the mesh extruding. The xcm mesh was removed. The patient was treated with vacuum therapy to close the wound. The procedure was successfully completed. The patient required an additional surgical procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2530154-2017-00006 |
| MDR Report Key | 7220113 |
| Report Source | DISTRIBUTOR,FOREIGN,USER FACI |
| Date Received | 2018-01-25 |
| Date of Report | 2018-01-25 |
| Date of Event | 2017-12-18 |
| Date Mfgr Received | 2017-12-28 |
| Device Manufacturer Date | 2017-08-04 |
| Date Added to Maude | 2018-01-25 |
| 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 | MRS. ALICE COUSENS |
| Manufacturer Street | 735 PENNSYLVANIA DRIVE |
| Manufacturer City | EXTON PA 19341 |
| Manufacturer Country | US |
| Manufacturer Postal | 19341 |
| Manufacturer Phone | 4847132165 |
| 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 | 2018-01-25 |
| Model Number | 30012-31 |
| Lot Number | E5614 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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. Hospitalization; 2. Required No Informationntervention | 2018-01-25 |