MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2006-10-18 for 5/12MM UNIVERSAL CONVERTER 1700 manufactured by Conmed Corp..
[610715]
It was reported that "part of the converter noticed inside abdomen during surgery and was retrieved by surgeon".
Patient Sequence No: 1, Text Type: D, B5
[7818178]
As soon as the engineer can evaluate the device and write his report, i will file a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1320894-2006-00082 |
| MDR Report Key | 837826 |
| Report Source | 01,06 |
| Date Received | 2006-10-18 |
| Date of Report | 2006-09-18 |
| Date of Event | 2006-09-08 |
| Date Mfgr Received | 2006-09-18 |
| Device Manufacturer Date | 2006-02-01 |
| Date Added to Maude | 2007-04-17 |
| 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 | 3 |
| 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 ROAD |
| 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 | 5/12MM UNIVERSAL CONVERTER |
| Generic Name | TROCAR SYSTEM SIZE CONVERTER |
| Product Code | FBM |
| Date Received | 2006-10-18 |
| Returned To Mfg | 2006-10-03 |
| Model Number | NA |
| Catalog Number | 1700 |
| Lot Number | 0602011 |
| ID Number | NA |
| Device Expiration Date | 2011-02-01 |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 825132 |
| Manufacturer | CONMED CORP. |
| Manufacturer Address | * UTICA NY * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-10-18 |