MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-01-04 for TOTAL PERFORMANCE SYSTEM SAW 5100-31 NA manufactured by Stryker Instruments.
[15744476]
Stryker saw was used on operation in the mouth. After operation when saw was removed, 3-4 cuts were noted at the right commissure of the mouth. They were 5-6 mm in length. The lacerations required suturing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 205072 |
| MDR Report Key | 205072 |
| Date Received | 1999-01-04 |
| Date of Report | 1998-11-16 |
| Date of Event | 1998-11-11 |
| Date Facility Aware | 1998-11-11 |
| Report Date | 1998-11-16 |
| Date Reported to Mfgr | 1998-12-03 |
| Date Added to Maude | 1999-01-11 |
| 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 | TOTAL PERFORMANCE SYSTEM SAW |
| Generic Name | OSCILLATING SAW |
| Product Code | DZH |
| Date Received | 1999-01-04 |
| Model Number | 5100-31 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 199059 |
| Manufacturer | STRYKER INSTRUMENTS |
| Manufacturer Address | 4100 EAST MILHAM AVE KALAMAZOO MI 49001 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 2 | 1. Required No Informationntervention | 1999-01-04 |