MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-08-22 for LYOPHILIZED DURA MATER TISSUE CATEGORY CODE TRF-010 * manufactured by Transplantation Research Foundation.
[28847]
Pt underwent surgery on 2/8/96 which included the use of freeze dried dura mater bone graft. Prior to implantation, the surgeon obtained a sample of the dura mater as soon as it was taken from the container. This was done using sterile technique. The sample was sent to the lab for c/s and anerobic cultures. On 2/12/96, the surgeon was notified that the microbiological report from the specimen was positive for "rare staphylococcus species (coagulase negative), beta lactamase".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4001714 |
| MDR Report Key | 51519 |
| Date Received | 1996-08-22 |
| Date of Report | 1996-02-12 |
| Date of Event | 1996-02-08 |
| Date Added to Maude | 1996-11-27 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LYOPHILIZED DURA MATER |
| Generic Name | LYOPHILIZED DURA MATER |
| Product Code | LEM |
| Date Received | 1996-08-22 |
| Model Number | TISSUE CATEGORY CODE TRF-010 |
| Catalog Number | * |
| Lot Number | D-8284-95 |
| ID Number | PO #801-6673A |
| Device Expiration Date | 1996-12-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 52188 |
| Manufacturer | TRANSPLANTATION RESEARCH FOUNDATION |
| Manufacturer Address | 4545 BISSONNET STE 285 BELLAIRE TX 77401 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-08-22 |