MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-02-15 for ACHILLES TENDON * FAT manufactured by Lifenet.
[21589564]
The pt had an acl reconstruction of the right knee with a cadaver graft. A couple of days prior to admission patient was not feeling well, had some increased swelling and pain. Two days prior to admission, was put on duricef. On the day of admission, woke up with excruciating pain in the right knee and went to the doctors office. Pt was admitted and taken to surgery for incision and drainage; the graft was visualized and looked fine. Pt was subsequently discharged home with orders for iv rocephin. Cultures grew out serratia. The pt was readmitted and had another incision and drainage, and was, discharged home to continue on iv zosyn. Approx 40 hours prior to readmission pt started to spike temperature, but no knee pain. Of concern was low white count of 1. 7. Picc line was examined.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1124603-2005-00004 |
| MDR Report Key | 574780 |
| Report Source | 05 |
| Date Received | 2005-02-15 |
| Date of Report | 2005-02-15 |
| Date Mfgr Received | 2005-02-07 |
| Date Added to Maude | 2005-02-23 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JERRY THOMPSON |
| Manufacturer Street | 5733 BAYSIDE ROAD SUITE 104 |
| Manufacturer City | VIRGINIA BEACH VA 23455 |
| Manufacturer Country | US |
| Manufacturer Postal | 23455 |
| Manufacturer Phone | 7572274547 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACHILLES TENDON |
| Generic Name | TENDON GRAFT |
| Product Code | LMO |
| Date Received | 2005-02-15 |
| Model Number | * |
| Catalog Number | FAT |
| Lot Number | 034508004 |
| ID Number | * |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 564628 |
| Manufacturer | LIFENET |
| Manufacturer Address | * VIRGINIA BEACH VA * US |
| Baseline Brand Name | ACHILLES TENDON |
| Baseline Generic Name | TENDON GRAFT |
| Baseline Model No | * |
| Baseline Catalog No | FAT |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2005-02-15 |