MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-05-03 for HOUSE CURETTES, 7 1/8", DOUBLE-ENDED, 2MMX2.5MM A * 385-400 manufactured by Hebumedical Gmbh.
[470895]
Customer reported during a tympanoplasty procedur, the cup of hte curette broke off. The surgeon doesn't know if the tip is in the pt's ear or flew off onto the drape or floor. The surgeon has scheduled an x-ray to cofirm. The surgeon reported that if the instrument piece is in the pt's ear. It should not cause any problems, however, the surgeon has questioned whether it is magnetic in the event pt requires an mri at a later time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2430952-2006-00017 |
| MDR Report Key | 710099 |
| Date Received | 2006-05-03 |
| Date of Report | 2006-05-01 |
| Date Facility Aware | 2006-03-31 |
| Report Date | 2006-05-01 |
| Date Added to Maude | 2006-05-11 |
| 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 | HOUSE CURETTES, 7 1/8", DOUBLE-ENDED, 2MMX2.5MM A |
| Generic Name | * |
| Product Code | FZS |
| Date Received | 2006-05-03 |
| Model Number | * |
| Catalog Number | 385-400 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 699147 |
| Manufacturer | HEBUMEDICAL GMBH |
| Manufacturer Address | * TUTTLINGEN * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-05-03 |