MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-11-07 for HOUSE CURETTES, 7 1/8", DOUBLE-ENDED, 2MM X 2.5MM A * 385-401 manufactured by Hebumedical Gmbh.
[563175]
Integra received a user facility voluntary 3500a form from the fda on september 8, 2006. The 3500a referenced which is not an integra / jarit product id. Upon receipt of the product on september 20, 2006, the device was identified as 385-401. The user facility reported that during a procedure, the currette tip broke off in the ear of the pt. The tip was recovered. Further info has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2430952-2006-00042 |
| MDR Report Key | 787107 |
| Date Received | 2006-11-07 |
| Date of Report | 2006-10-06 |
| Date Facility Aware | 2006-09-08 |
| Report Date | 2006-10-06 |
| Date Added to Maude | 2006-11-29 |
| 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 |
| 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 | HOUSE CURETTES, 7 1/8", DOUBLE-ENDED, 2MM X 2.5MM A |
| Generic Name | JARIT EAR/NOSE |
| Product Code | JYG |
| Date Received | 2006-11-07 |
| Returned To Mfg | 2006-09-20 |
| Model Number | * |
| Catalog Number | 385-401 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 774870 |
| Manufacturer | HEBUMEDICAL GMBH |
| Manufacturer Address | * TUTTLINGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-11-07 |