MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2007-06-07 for CORE ENTREE II VALVE/REDUCER CD775 manufactured by Conmed Corp..
[668909]
It was reported that "pieces of seal fell in abdomen of pt". No apparent injury to pt.
Patient Sequence No: 1, Text Type: D, B5
[7974803]
When the investigation has been completed, i will submit a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1320894-2007-00103 |
| MDR Report Key | 862012 |
| Report Source | 05,06,07 |
| Date Received | 2007-06-07 |
| Date of Report | 2007-06-07 |
| Date of Event | 2007-04-30 |
| Date Mfgr Received | 2007-05-14 |
| Date Added to Maude | 2007-07-13 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SHARON RUSZALA |
| Manufacturer Street | 525 FRENCH RD. |
| Manufacturer City | UTICA NY 13502 |
| Manufacturer Country | US |
| Manufacturer Postal | 13502 |
| Manufacturer Phone | 3156243076 |
| Manufacturer G1 | CONMED CORP. |
| Manufacturer Street | 525 FRENCH RD. |
| Manufacturer City | UTICA NY 13502 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 13502 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CORE ENTREE II VALVE/REDUCER |
| Generic Name | ENDO VALVE REDUCER |
| Product Code | FBM |
| Date Received | 2007-06-07 |
| Model Number | NA |
| Catalog Number | CD775 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 855080 |
| Manufacturer | CONMED CORP. |
| Manufacturer Address | UTICA NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-06-07 |