MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-05-15 for manufactured by Zimmer Orthopaedic Surgical Products.
[21437774]
Hosp was contacted by zimmer osp on two occasions to try and obtain device for eval. The risk mgr has stated that the device is being retained at the hosp. However, she will try to follow-up with photos.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1035617-2008-00002 |
| MDR Report Key | 1098943 |
| Report Source | 05 |
| Date Received | 2008-05-15 |
| Date Reported to Mfgr | 2008-04-16 |
| Date Added to Maude | 2008-08-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DEBARA REESE |
| Manufacturer Street | 200 W OHIO AVE |
| Manufacturer City | DOVER OH 44622 |
| Manufacturer Country | US |
| Manufacturer Postal | 44622 |
| Manufacturer Phone | 3303649483 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | ILZ |
| Date Received | 2008-05-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NO INFO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 984014 |
| Manufacturer | ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS |
| Manufacturer Address | 2021 OLD MOUNTAIN RD STATESVILLE NC * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-05-15 |