MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-08-24 for JARIT AU12452 * manufactured by Jarit Instruments.
[502751]
Curette tip broke off in right ear during surgery. Tip of curette was recovered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1040157 |
| MDR Report Key | 755760 |
| Date Received | 2006-08-24 |
| Date of Report | 2006-08-11 |
| Date of Event | 2006-07-31 |
| Date Added to Maude | 2006-08-31 |
| 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 | 3 |
| 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 | JARIT |
| Generic Name | DOUBLE ENDED CURETTE |
| Product Code | FZS |
| Date Received | 2006-08-24 |
| Model Number | AU12452 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 743596 |
| Manufacturer | JARIT INSTRUMENTS |
| Manufacturer Address | 9 SKYLINE DR HAWTHORNE NY 10532 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-08-24 |