MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-11-29 for RING CURETTE NL 6735 * manufactured by Carefusion.
[2509146]
While surgeon performing a right l5-s1 lumbar laminectomy, disectomy, the tip of a #4 ring curette broke off. Tip of the ring curette was retrieved with no resulting injury to the patient. Removal of piece was confirmed with x-ray.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2363227 |
MDR Report Key | 2363227 |
Date Received | 2011-11-29 |
Date of Report | 2011-11-29 |
Date of Event | 2011-11-28 |
Report Date | 2011-11-29 |
Date Reported to FDA | 2011-11-29 |
Date Added to Maude | 2011-12-08 |
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 | 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 | RING CURETTE |
Generic Name | RING CURETTE |
Product Code | HTF |
Date Received | 2011-11-29 |
Model Number | NL 6735 |
Catalog Number | * |
Lot Number | * |
ID Number | * |
Operator | PHYSICIAN |
Device Availability | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | CAREFUSION |
Manufacturer Address | 5 SUNNEN DRIVE SAINT LOUIS MO 63143 US 63143 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2011-11-29 |