MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-11-02 for DANDY 8 1/2' STRAIGHT NL 2491 * manufactured by Cardinal Health.
[547220]
During operation the scrub tech asked for another nerve hook as the one he was using had "broken. " the tip of the hook had fallen off. The scrub tech indicated it had fallen onto the floor. The floor was searched, unable to locate tip. X-ray taken, no metal foreign objects found on examination of x-ray. Unknown what happened to tip. Equipment removed from service and a new nerve hook obtained. No injury to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 782183 |
| MDR Report Key | 782183 |
| Date Received | 2006-11-02 |
| Date of Report | 2006-11-02 |
| Date of Event | 2006-10-16 |
| Report Date | 2006-11-02 |
| Date Reported to FDA | 2006-11-02 |
| Date Added to Maude | 2006-11-20 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| 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 | DANDY 8 1/2' STRAIGHT |
| Generic Name | HOOK, NERVE |
| Product Code | GZX |
| Date Received | 2006-11-02 |
| Model Number | NL 2491 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | N |
| Device Age | 2 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 769980 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | MEDICAL PRODUCTS AND SERVICES 1430 WAUKEGAN ROAD MCGAW PARK IL 600856787 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-11-02 |