MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-06-22 for BRUNS OVAL CUP CURETTES, 9", STRAIGHT, SIZE 3-0 * 240-120 manufactured by Chirurgische Instrumente.
[17110463]
After the purchase of the curettes in early april the new currette was put into service. The currette bent within five business days. The customer reported that the instrument was in contact with a patient. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2430952-2006-00028 |
| MDR Report Key | 727833 |
| Date Received | 2006-06-22 |
| Date of Report | 2006-06-22 |
| Date Facility Aware | 2006-05-17 |
| Report Date | 2006-06-15 |
| Date Added to Maude | 2006-06-23 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | BRUNS OVAL CUP CURETTES, 9", STRAIGHT, SIZE 3-0 |
| Generic Name | JARIT ORTHOPEDIC SURGERY |
| Product Code | FZS |
| Date Received | 2006-06-22 |
| Model Number | * |
| Catalog Number | 240-120 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 716139 |
| Manufacturer | CHIRURGISCHE INSTRUMENTE |
| Manufacturer Address | * TUTTLINGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-06-22 |