MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-08-05 for ASPIRATING NEEDLE * 50-7453 manufactured by Pilling Surgical.
[17766892]
The needle detached from the instrument during use, and was able to be retrieved by the dr.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 492600 |
| MDR Report Key | 492600 |
| Date Received | 2003-08-05 |
| Date of Report | 2003-06-12 |
| Date of Event | 2003-06-11 |
| Date Facility Aware | 2003-06-12 |
| Report Date | 2003-06-12 |
| Date Added to Maude | 2003-11-03 |
| 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 |
| 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 | ASPIRATING NEEDLE |
| Generic Name | ASPIRATING NEEDLE |
| Product Code | GDM |
| Date Received | 2003-08-05 |
| Model Number | * |
| Catalog Number | 50-7453 |
| Lot Number | DD9 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 481306 |
| Manufacturer | PILLING SURGICAL |
| Manufacturer Address | 200 PRECISION RD. SUITE 200 HORSHAM PA 19044 US |
| Baseline Brand Name | ASPIRATING NEEDLE |
| Baseline Generic Name | NEEDLE, ASPIRATION & INJECTION, REUSABLE |
| Baseline Model No | 50-7453 |
| Baseline Catalog No | 50-7453 |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-08-05 |