MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 2005-12-05 for UNIVERSAL REDUCER 5/10/12MM 3-HOLE CD513B manufactured by Conmed Corp..
[405558]
It was reported that, "the 10mm seal was pushed into the pt's abdomen. It was retrieved. There was no pt injury and the procedure was not altered. The surgical time was extended to retrieve the piece.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1317214-2005-00126 |
| MDR Report Key | 649450 |
| Report Source | 06,08 |
| Date Received | 2005-12-05 |
| Date of Report | 2005-12-04 |
| Date of Event | 2005-11-04 |
| Date Mfgr Received | 2005-11-04 |
| Date Added to Maude | 2005-12-07 |
| 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 | NANCY CRISINO, SUPERVISOR |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 13502 |
| Manufacturer Country | US |
| Manufacturer Postal | 13502 |
| Manufacturer Phone | 3156243078 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNIVERSAL REDUCER 5/10/12MM 3-HOLE |
| Generic Name | SURGICAL TROCAR SYSTEM REDUCER |
| Product Code | FBQ |
| Date Received | 2005-12-05 |
| Returned To Mfg | 2005-11-09 |
| Model Number | NA |
| Catalog Number | CD513B |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 638941 |
| Manufacturer | CONMED CORP. |
| Manufacturer Address | * UTICA NY 13501 US |
| Baseline Brand Name | UNIVERSAL REDUCER 5/10/12MM |
| Baseline Generic Name | UNIVERSAL REDUCER |
| Baseline Model No | NA |
| Baseline Catalog No | CD513B |
| Baseline ID | NA |
| Baseline Device Family | SURGICAL TROCAR SYSTEM |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K911813 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-12-05 |