MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-06-09 for RICHARDS R 23-0594 * manufactured by Smith And Nephew, Inc. Orthopaedic Div..
[140585]
Dr went to use sicle knife. Made incision and blade broke off. Dr able to retrieve broken blade from sinus.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1016501 |
| MDR Report Key | 227111 |
| Date Received | 1999-06-09 |
| Date of Report | 1999-06-09 |
| Date of Event | 1999-05-21 |
| Date Added to Maude | 1999-06-16 |
| 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 | RISK MANAGER |
| 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 | RICHARDS |
| Generic Name | SICLE KNIFE |
| Product Code | EMF |
| Date Received | 1999-06-09 |
| Model Number | R 23-0594 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | RB7 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 220219 |
| Manufacturer | SMITH AND NEPHEW, INC. ORTHOPAEDIC DIV. |
| Manufacturer Address | 1450 BROOKS RD. MEMPHIS TN 38116 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 1999-06-09 |