MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-03-29 for BRAUN TENACULUM FORCEPS, 10" * 505-205 manufactured by Conqueror Surgical Industries.
[438602]
The tip broke off during obgyn case (tube inspection). The tip was retrieved and there was no patient injury reported. The tip was reported to be returned, but jarit only received the instrument which will be sent to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2430952-2006-00011 |
| MDR Report Key | 693713 |
| Date Received | 2006-03-29 |
| Date of Report | 2006-03-28 |
| Date Facility Aware | 2006-02-27 |
| Report Date | 2006-03-28 |
| Date Reported to FDA | 2006-03-28 |
| Date Added to Maude | 2006-04-03 |
| 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 | BRAUN TENACULUM FORCEPS, 10" |
| Generic Name | JARIT OBSTERICS/GYNECOLOGY |
| Product Code | HDC |
| Date Received | 2006-03-29 |
| Model Number | * |
| Catalog Number | 505-205 |
| Lot Number | 106C482 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 682841 |
| Manufacturer | CONQUEROR SURGICAL INDUSTRIES |
| Manufacturer Address | * SIALKOT PK |
| Baseline Brand Name | BRAUN TENACULUM FORCEPS, 10" |
| Baseline Generic Name | JARIT OBSTERICS/GYNECOLOGY |
| Baseline Model No | * |
| Baseline Catalog No | 505-205 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-03-29 |