MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2003-08-05 for manufactured by .
| Report Number | 2515651-2003-00003 |
| MDR Report Key | 492608 |
| Report Source | 06 |
| Date Received | 2003-08-05 |
| Date of Event | 2003-06-11 |
| Date Mfgr Received | 2003-07-14 |
| Device Manufacturer Date | 1999-04-01 |
| Date Added to Maude | 2003-11-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | BRADLEY SEIDEN MANAGER |
| Manufacturer Street | 200 PRECISION RD, SUITE 200 |
| Manufacturer City | HORSHAM PA 19044 |
| Manufacturer Country | US |
| Manufacturer Postal | 19044 |
| Manufacturer Phone | 2154428892 |
| Manufacturer G1 | PILLING SURGICAL |
| Manufacturer Street | 200 PRECISION RD, SUITE 200 |
| Manufacturer City | HORSHAM PA 19044 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19044 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | GDM |
| Date Received | 2003-08-05 |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 481306 |
| 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 |