MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2000-04-05 for 52-1310 manufactured by Pilling Weck Surgical.
| Report Number | 2515651-2000-00001 |
| MDR Report Key | 272732 |
| Report Source | 07 |
| Date Received | 2000-04-05 |
| Date of Report | 2000-04-05 |
| Date of Event | 2000-02-19 |
| Date Mfgr Received | 2000-03-03 |
| Date Added to Maude | 2000-04-11 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHARLOTTE CLEGG |
| Manufacturer Street | 420 DELAWARE DR |
| Manufacturer City | FT. WASHINGTON PA 19038 |
| Manufacturer Country | US |
| Manufacturer Postal | 19038 |
| Manufacturer Phone | 8005232579 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | HBI |
| Date Received | 2000-04-05 |
| Model Number | 52-1310 |
| Catalog Number | 52-1310 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 264031 |
| Manufacturer | PILLING WECK SURGICAL |
| Manufacturer Address | 420 DELAWARE DR FT WASHINGTON PA 19034 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-04-05 |