MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-08-12 for RUGGLES MICRO-CURETT * R13-0148 manufactured by Smith & Nephew Richa.
[321262]
Tip of ebonized double-ended micro-curette broke off during procedure. Thought to be retained in pt's ear but x-ray revealed no foreign object.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 478330 |
| MDR Report Key | 478330 |
| Date Received | 2003-08-12 |
| Date of Report | 2003-08-05 |
| Date of Event | 2003-07-31 |
| Date Facility Aware | 2003-07-31 |
| Report Date | 2003-08-05 |
| Date Reported to FDA | 2003-08-05 |
| Date Reported to Mfgr | 2003-08-05 |
| Date Added to Maude | 2003-08-20 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | RUGGLES MICRO-CURETT |
| Generic Name | CURETTE |
| Product Code | FZS |
| Date Received | 2003-08-12 |
| Model Number | * |
| Catalog Number | R13-0148 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 467138 |
| Manufacturer | SMITH & NEPHEW RICHA |
| Manufacturer Address | 1450 BROOKS ROAD MEMPHIS TN 38116 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-08-12 |