MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2006-10-24 for UNIVERSAL REDUCER 5/10/12MM CD5138 manufactured by Conmed Corporation.
[694960]
It was reported that "pieces of the core rubber 3 hole reducer fell off into the patient. Pieces were retrieved. "
Patient Sequence No: 1, Text Type: D, B5
[8127309]
The investigation results on the returned product concluded that the product was assembled properly. However, the seal was torn and it was concluded the insertion of an instrument through the cannula caused the seal to stretch beyond its design and tear. The investigation is completed, and the complaint closed at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1320894-2006-00090 |
| MDR Report Key | 892107 |
| Report Source | 01,06,07 |
| Date Received | 2006-10-24 |
| Date of Report | 2006-10-02 |
| Date of Event | 2006-01-01 |
| Date Mfgr Received | 2006-10-02 |
| Device Manufacturer Date | 2006-04-01 |
| Date Added to Maude | 2007-08-10 |
| 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 ROAD |
| Manufacturer City | UTICA NY 13502 |
| Manufacturer Country | US |
| Manufacturer Postal | 13502 |
| Manufacturer Phone | 3156243076 |
| Manufacturer G1 | CONMED CORPORATION |
| 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 | UNIVERSAL REDUCER 5/10/12MM |
| Generic Name | UNIVERSAL REDUCER |
| Product Code | FBQ |
| Date Received | 2006-10-24 |
| Returned To Mfg | 2006-10-06 |
| Model Number | NA |
| Catalog Number | CD5138 |
| Lot Number | 0604261 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 869016 |
| Manufacturer | CONMED CORPORATION |
| Manufacturer Address | * UTICA NY * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-10-24 |