MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2016-03-11 for XCM BIOLOGIC TISSUE MATRIX XM106.2030S manufactured by Dsm Biomedical.
[40157227]
Review of the device history records does not have deviations that would contribute to the reported event. The product met all pre-determined acceptance criteria. Review of sterilization records indicate the product was processed in accordance with product requirements and met all pre-determined acceptance criteria for sterility. The cause of the event can not be determined from the provided information or the manufacturing records. Additional clinical information has been requested. If additional information is received, it will be reported in a follow-up report. Not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[40157228]
The patient had xcm biologic implanted as part of an unknown surgical procedure in the abdomen. It was reported that the patient complained of pain on the third post-operative day. Unknown diagnostic tests were performed that revealed abdominal eventration. On the fourth post-operative day, the patient was brought back to the operating theater for revision. The surgeon observed several small holes in the mesh. The mesh was explanted and replaced with another surgical mesh. The patient is reportedly in good condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2530154-2016-00006 |
| MDR Report Key | 5495033 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2016-03-11 |
| Date of Report | 2016-03-11 |
| Date of Event | 2016-01-28 |
| Date Mfgr Received | 2016-02-15 |
| Device Manufacturer Date | 2014-07-31 |
| Date Added to Maude | 2016-03-11 |
| 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 |
| 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 | 2016-03-11 |
| Model Number | XM106.2030S |
| Lot Number | KNC1027 |
| Device Expiration Date | 2017-06-30 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2016-03-11 |