MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-06-16 for KITTNER BLUNT DISSECTORS CD802 manufactured by Conmed Corporation.
[1637204]
It was reported, "package is unsealed at the top end times ten (10) packages. " this is a sterile product. Also reported never utilized on patient.
Patient Sequence No: 1, Text Type: D, B5
[8617638]
The devices are being returned to conmed however, have not been received to date. Supplemental reports will be filed when quality engineering investigations are complete. Associated medwatch reports: 1320894-2010-00086, 87,88,89,90,91,92,93,and 95.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1320894-2010-00094 |
| MDR Report Key | 1731129 |
| Report Source | 06 |
| Date Received | 2010-06-16 |
| Date of Report | 2010-06-16 |
| Date Mfgr Received | 2010-05-14 |
| Device Manufacturer Date | 2009-10-01 |
| Date Added to Maude | 2011-01-31 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | STEPHEN CASANOVA, RN, MPS, SPECIA |
| Manufacturer Street | 525 FRENCH RD. |
| Manufacturer City | UTICA NY 135025994 |
| Manufacturer Country | US |
| Manufacturer Postal | 135025994 |
| Manufacturer Phone | 3156243463 |
| Manufacturer G1 | CONMED CORPORATION |
| Manufacturer Street | 525 FRENCH RD. |
| Manufacturer City | UTICA NY 13502599 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 13502 5994 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KITTNER BLUNT DISSECTORS |
| Generic Name | KITTNER BLUNT DISSECTORS |
| Product Code | GDI |
| Date Received | 2010-06-16 |
| Model Number | NA |
| Catalog Number | CD802 |
| Lot Number | 09100881 |
| ID Number | NA |
| Device Expiration Date | 2014-10-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORPORATION |
| Manufacturer Address | UTICA NY 13502 US 13502 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-06-16 |