MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-12-28 for STRYKER COMMAND 2 UNK manufactured by Stryker Instruments Division Of Stryker Corporation.
[136576]
Add'l info rec'd 10/28/99: pt has been unable to bring her talent and future aspects back to the level it once was due to her lip and tongue burn injuries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1015306 |
| MDR Report Key | 203913 |
| Date Received | 1998-12-28 |
| Date of Report | 1998-12-28 |
| Date of Event | 1998-01-14 |
| Date Added to Maude | 1998-12-31 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRYKER |
| Generic Name | HANDPIECE/DRILL |
| Product Code | DZH |
| Date Received | 1998-12-28 |
| Model Number | COMMAND 2 |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 198060 |
| Manufacturer | STRYKER INSTRUMENTS DIVISION OF STRYKER CORPORATION |
| Manufacturer Address | 4100 MILNAM AVE KALAMAZOO MI 49001 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 1998-12-28 |