MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-09-13 for HOUSE CURETTES, 7 1/8", DOUBLE-ENDED, 2MMX2.5MM * 385-400 manufactured by Hebumedical Gmbh.
[17488749]
The user facility reported that during a tympanoplasty procedure, the cup of the curette broke off. The surgeon was not sure if the tip was in the pt's ear or had fell on to the drape or the floor. An x-ray was performed, and the surgeon found that the cup had not broken off into the pt's ear.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2430952-2006-00035 |
| MDR Report Key | 761133 |
| Date Received | 2006-09-13 |
| Date of Report | 2006-09-04 |
| Date Facility Aware | 2006-03-21 |
| Report Date | 2006-09-04 |
| Date Added to Maude | 2006-09-18 |
| 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 |
| Generic Name | CURETTE |
| Product Code | KAP |
| Date Received | 2006-09-13 |
| Returned To Mfg | 2006-05-19 |
| Model Number | * |
| Catalog Number | 385-400 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 749055 |
| Manufacturer | HEBUMEDICAL GMBH |
| Manufacturer Address | * TUTTINGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-09-13 |