MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2002-05-21 for SYNVISC manufactured by Genzyme Biosurgery/alex Kuta-genzyme Biosurgery.
[230151]
Septic arthritis. Report received from a physician regarding a pt. The pt received synvisc injection to the knee in 2002 (3 days and 4 days later) and subsequently developed septic arthritis in the right knee. Two days later, the pt was hospitalized and received surgical debridement of right knee. The physician also reported that there was an aspiration of pus during the debridement. The pt received i. V. Vancomycin for 6 weeks. The pt was discharged from the hospital (date unk) and is considered completely recovered. Corrective treatment: surgical, debridement, 6 weeks of i. V. Vancomycin.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2246315-2002-00013 |
| MDR Report Key | 395636 |
| Report Source | 05,08 |
| Date Received | 2002-05-21 |
| Date of Report | 2002-05-20 |
| Date of Event | 2002-03-01 |
| Date Mfgr Received | 2002-04-25 |
| Date Added to Maude | 2002-05-23 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ALEX KUTA |
| Manufacturer Street | ONE KENDALL SQUARE |
| Manufacturer City | CAMBRIDGE MA 021391562 |
| Manufacturer Country | US |
| Manufacturer Postal | 021391562 |
| Manufacturer Phone | 6172527500 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNVISC |
| Generic Name | HYLAN G-F 20 |
| Product Code | MDZ |
| Date Received | 2002-05-21 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 384642 |
| Manufacturer | GENZYME BIOSURGERY/ALEX KUTA-GENZYME BIOSURGERY |
| Manufacturer Address | ONE KENDALL SQUARE CAMBRIDGE MA 021391562 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-05-21 |