MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2016-10-05 for XCM BIOLOGIC TISSUE MATRIX 30010-34 XM1062535T manufactured by Dsm Biomedical.
[56462589]
Lot number has not been provided. Additional clinical information has been requested, but not available as of date of this report.
Patient Sequence No: 1, Text Type: N, H10
[56462590]
It was reported by the surgeon that a patient underwent a component separation, done through a large chevron incision, and had a large piece of xcm biologic tissue matrix placed in the retrorectus space without sutures. Six months post-op, the patient presented with a flank hernia on one side of the chevron. During laparoscopic surgery to repair the hernia, the surgeon noted that where the hernia developed the tissue was soft, as if the previously placed xcm biologic tissue matrix was no longer present.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2530154-2016-00014 |
| MDR Report Key | 5999709 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2016-10-05 |
| Date of Report | 2016-10-04 |
| Date of Event | 2016-02-20 |
| Date Mfgr Received | 2016-09-06 |
| Date Added to Maude | 2016-10-05 |
| 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 |
| 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 | 2016-10-05 |
| Model Number | 30010-34 |
| Catalog Number | XM1062535T |
| 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 PENNSLYVANIA DRIVE EXTON PA 19341 US 19341 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-10-05 |