MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2003-08-26 for * manufactured by Pilling Surgical.
| Report Number | 2515651-2003-00004 |
| MDR Report Key | 480288 |
| Report Source | 06 |
| Date Received | 2003-08-26 |
| Date of Event | 2003-05-01 |
| Date Mfgr Received | 2003-07-30 |
| Date Added to Maude | 2003-08-29 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | BRADLEY SEIDEN, MGR |
| Manufacturer Street | 200 PRECISION RD SUITE 200 |
| Manufacturer City | HORSHAM PA 19044 |
| Manufacturer Country | US |
| Manufacturer Postal | 19044 |
| Manufacturer Phone | 2154428892 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | * |
| Product Code | KBN |
| Date Received | 2003-08-26 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 469135 |
| Manufacturer | PILLING SURGICAL |
| Manufacturer Address | 200 PRECISION RD. SUITE 200 HORSHAM PA 19044 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-08-26 |