MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-02-12 for XCM BIOLOGIC TISSUE MATRIX 30012-03 manufactured by Dsm Biomedical.
[99816059]
No lot number was provided for the device; therefore no manufacturing review or quality control review have been performed. Additional information was requested from the submitter. A follow-up report will be provided if any additional information becomes available. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[99816060]
It was reported that there was an opinion of an infection after the surgery, and the infection was confirmed by a re-operation to remove the product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2530154-2018-00002 |
| MDR Report Key | 7263733 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2018-02-12 |
| Date of Report | 2018-02-08 |
| Date Mfgr Received | 2018-01-11 |
| Date Added to Maude | 2018-02-12 |
| 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 | 2018-02-12 |
| Model Number | 30012-03 |
| 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. Required No Informationntervention | 2018-02-12 |