MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-02-28 for CARTICEL NI manufactured by Genzyme Tissue Repair.
[264429]
Pt had surgery for anteromedialization and bipolar patellofemoral autologous-cultured chondrocyte implantation deep microsuture periosteal patches. The next day developed fever, pain, and elevated white count to 27,000. Diagnosed as septic joint in operative knee. Open debridement and removal of the carticel cells implant one day later.
Patient Sequence No: 1, Text Type: D, B5
[316629]
Add'l info received from mfr 4-3-03: letter contains info concerning an adverse event experienced after implantation of carticel (autologous cultured chondrocytes). Genzymes biosurgery manufactures carticel under a biologics license application and adverse event reports are submitted per 21 cfr 600. 80. The info they received regarding the referenced event was submitted to the center for biologics evaluation and research on march 11, 2003 on medwatch form 3500a.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 445387 |
| MDR Report Key | 445387 |
| Date Received | 2003-02-28 |
| Date of Report | 2003-02-26 |
| Date of Event | 2003-02-20 |
| Date Facility Aware | 2003-02-25 |
| Report Date | 2003-02-26 |
| Date Reported to FDA | 2003-02-26 |
| Date Reported to Mfgr | 2003-02-26 |
| Date Added to Maude | 2003-03-04 |
| 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 | CARTICEL |
| Generic Name | CARTILAGE IMPLANT |
| Product Code | NCO |
| Date Received | 2003-02-28 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 434361 |
| Manufacturer | GENZYME TISSUE REPAIR |
| Manufacturer Address | 64 SIDNEY ST CAMBRIDGE MA 021394136 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2003-02-28 |