MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-01-13 for CUR C-L ANG VIO CS#4-0 10" U-0164 manufactured by Cardinal Health.
[19256045]
The tip broke of while physician was performing lumbar decompression on a pt. The physician completed the procedure with another curette and completed the case. The pt was sent to x-ray, but the broken piece was not found.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2005-00005 |
| MDR Report Key | 565540 |
| Report Source | 05 |
| Date Received | 2005-01-13 |
| Date of Report | 2005-01-13 |
| Date Mfgr Received | 2004-12-15 |
| Date Added to Maude | 2005-01-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Manufacturer Contact | MICHELE DONALICH |
| Manufacturer Street | 1430 WAUKEGAN RD, BLDG KB |
| Manufacturer City | MCGAW IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8475786412 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CUR C-L ANG VIO CS#4-0 10" |
| Generic Name | CURETTE |
| Product Code | FZS |
| Date Received | 2005-01-13 |
| Returned To Mfg | 2005-01-13 |
| Model Number | U-0164 |
| Catalog Number | U-0164 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 555328 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | * MCGAW PARK IL * US |
| Baseline Brand Name | CUR C-L AND VIO CS#4-0 10" |
| Baseline Generic Name | CURETTE C-; ANG VIO CS#4-0 10" |
| Baseline Model No | U-0164 |
| Baseline Catalog No | U-0164 |
| Baseline ID | NA |
| Baseline Device Family | CURETTES |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-01-13 |