MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-17 for XCM BIOLOGIC TISSUE MATRIX manufactured by Dsm Biomedical.
[31453298]
The mesh tears were repaired during the planned second stage procedure. Therefore, the device remains in the patient and will not be returned for evaluation. No photographs of the device have been provided for evaluation. No model number and lot number have been provided. Therefore, no device evaluation or manufacturing record review could be performed. In addition, no information has been provided about the patient's demographics, method of mesh implantation or concomitant medical products used. Multiple attempts have been made to obtain additional clinical information. If additional information is provided, it will be reported in a follow-up mdr.
Patient Sequence No: 1, Text Type: N, H10
[31453299]
It was reported that xcm biologic was implanted in a patient as part of a complex, multi-stage abdominal surgical procedure that involved colon resection and repair of multiple fistulas. At the end of the procedure, the surgical wound was left open due to the complexity of the case and wound closure was planned for the following day. During the second stage of the procedure, the surgeon observed 'some small tears' in the mesh. The tears were repaired during the second stage procedure and the surgical wound was closed. No clinical consequences were observed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2530154-2015-00004 |
| MDR Report Key | 5231292 |
| Date Received | 2015-11-17 |
| Date of Report | 2015-11-17 |
| Date of Event | 2015-10-14 |
| Date Mfgr Received | 2015-10-19 |
| Date Added to Maude | 2015-11-17 |
| 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 |
| Manufacturer G1 | DSM BIOMEDICAL |
| Manufacturer Street | 735 PENNSYLVANIA DRIVE |
| Manufacturer City | EXTON PA 19341 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | XCM BIOLOGIC TISSUE MATRIX |
| Generic Name | MESH, SURGICAL, COLLAGEN, LARGE ABDOMINAL WALL DEFECTS |
| Product Code | OXK |
| Date Received | 2015-11-17 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2015-11-17 |