MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2018-09-19 for XCM BIOLOGIC TISSUE MATRIX 30013-30, -32 manufactured by Dsm Biomedical Inc..
[120693713]
Based on the nature of the complaint, rapid absorption of the device is currently captured appropriately within dsm's risk analysis for the xcm biologic tissue matrix. A product/process review was deemed an appropriate technique for reviewing all process and batch data to ensure compliance with the product requirements. The batch records for the lot were reviewed, and no discrepancies were observed that would have negatively impacted the performance of the device. Existing controls and mitigations in place were reviewed in (b)(4). Upon review of the risk assessment and current controls in place, it was determined that the controls referenced in the risk analysis remain acceptable and applicable at this time. No assignable root cause can be determined at this time.
Patient Sequence No: 1, Text Type: N, H10
[120693714]
Patient is a (b)(6) year-old female with a bmi of 32. On the (b)(6), xcm biologic mesh was inserted after a bowel resection for peritonitis secondary to a small bowel tear during a massive ventral hernia repair with progressive pneumoperitoneum. Patient had several vacuum assisted closures (vac) performed. During the vac on (b)(6), it was noted that the xcm mesh had weakened. During the vac on the (b)(6), it was noted that the right side of the mesh had liquified. During the vac on the (b)(6), it was noted that the xcm biologic mesh had completely disappeared. Bridging of the wound occurred. The device was inserted into an area suspected of being infected but the patient did not have a fever, nor were any bacterial cultures obtained. The patient was left with an open abdomen with enteroathmospheric fistulas.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2530154-2018-00005 |
| MDR Report Key | 7888644 |
| Report Source | FOREIGN |
| Date Received | 2018-09-19 |
| Date of Report | 2018-09-17 |
| Date of Event | 2018-07-06 |
| Date Mfgr Received | 2018-08-18 |
| Device Manufacturer Date | 2017-12-14 |
| Date Added to Maude | 2018-09-19 |
| 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 |
| 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 | 2018-09-19 |
| Model Number | 30013-30, -32 |
| Lot Number | C8203, E8358 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DSM BIOMEDICAL INC. |
| Manufacturer Address | 735 PENNSYLVANIA DRIVE EXTON PA 19341 US 19341 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-09-19 |