MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1997-02-26 for OSCILLATING SAW RETROFIT 0296-319-000 NA manufactured by Stryker Instruments.
[41363]
Oil leaking out. Pt was given antibiotics and the site was debrided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1811755-1997-00025 |
| MDR Report Key | 72790 |
| Report Source | 06 |
| Date Received | 1997-02-26 |
| Date Mfgr Received | 1997-01-30 |
| Device Manufacturer Date | 1991-04-01 |
| Date Added to Maude | 1997-03-05 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OSCILLATING SAW RETROFIT |
| Generic Name | SAW |
| Product Code | DZH |
| Date Received | 1997-02-26 |
| Model Number | 0296-319-000 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 6 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 72652 |
| Manufacturer | STRYKER INSTRUMENTS |
| Manufacturer Address | 4100 E. MILHAM AVE. KALAMAZOO MI 49001 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-02-26 |