MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-03-18 for LIFENET manufactured by Lifenet.
[283155]
Product mislabeled as whole patella ligament. The graft was unthawed & prepared for use. The graft was identified as being of a different type. The physician was notified and stated that this graft would work. He consulted with the familty and notified them on his intentions. The family consented. The case proceeded well and with no adverse reactions. The pt required no additional treatment or medications.
Patient Sequence No: 1, Text Type: D, B5
[17801588]
Add'l info received from mfr 5/6/03: the product referenced in the report is a frozen achilles tendon, classified as human tissue by the center for biologics evaluation and research.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 448769 |
| MDR Report Key | 448769 |
| Date Received | 2003-03-18 |
| Date of Report | 2003-03-18 |
| Date of Event | 2003-03-11 |
| Date Facility Aware | 2003-03-11 |
| Date Reported to FDA | 2003-03-19 |
| Date Added to Maude | 2003-03-21 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIFENET |
| Generic Name | PATELLAR LIGAMENT |
| Product Code | LML |
| Date Received | 2003-03-18 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | 02-1252-004 |
| ID Number | NA |
| Device Expiration Date | 2007-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 437749 |
| Manufacturer | LIFENET |
| Manufacturer Address | 5809 WARD COURT VIRGINIA BEACH VA 23455 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-03-18 |