MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,08 report with the FDA on 2014-06-09 for XCM BIOLOGIC TISSUE MATRIX manufactured by Dsm Biomedical.
[19720646]
It was reported that xcm biologic was implanted for an unknown surgical procedure. Three weeks later, revision surgery was performed due to tumor margins. It was reported that the "xcm sheet had deteriorated and appeared as a sloughy area instead of chest wall tissue. " the patient experienced no associated adverse events.
Patient Sequence No: 1, Text Type: D, B5
[19821304]
Multiple attempts have been made to obtain additional device and clinical information. However, as of the date of this report, no investigation could be completed since the device part and lot number information has not been provided. If the requested information is provided, it will be reported in a follow-up mdr.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2530154-2014-00006 |
| MDR Report Key | 3960685 |
| Report Source | 01,05,08 |
| Date Received | 2014-06-09 |
| Date of Report | 2014-06-12 |
| Date of Event | 2013-10-23 |
| Date Mfgr Received | 2014-05-12 |
| Date Added to Maude | 2014-08-04 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | 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, THORACIC |
| Product Code | OXB |
| Date Received | 2014-06-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DSM BIOMEDICAL |
| Manufacturer Address | EXTON PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-09 |