MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1996-12-18 for PRESSURE MONITOR 0295-000-000 NA manufactured by Stryker Instruments.
[37163]
Product was used on pt and pt was later diagnosed with compartmental syndrome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1811755-1996-00265 |
| MDR Report Key | 58206 |
| Report Source | 00 |
| Date Received | 1996-12-18 |
| Date of Event | 1993-06-21 |
| Date Mfgr Received | 1996-10-09 |
| Date Added to Maude | 1996-12-27 |
| 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 |
| Reporter Occupation | ATTORNEY |
| 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 | PRESSURE MONITOR |
| Generic Name | PRESSURE MONITOR |
| Product Code | LXC |
| Date Received | 1996-12-18 |
| Model Number | 0295-000-000 |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | NA |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 58687 |
| Manufacturer | STRYKER INSTRUMENTS |
| Manufacturer Address | 4100 E MILHAM AVE KALAMAZOO MI 49001 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 1996-12-18 |