MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-12-10 for SUREFIT 410-2000 manufactured by Conmed Corporation.
[1391730]
It was reported that "the pad seemed very dry and not lubricated as it is supposed to be and there was a slight reddish area where the pad was. "
Patient Sequence No: 1, Text Type: D, B5
[8343722]
The actual device will not be returned. When the investigation is complete, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1320894-2009-00134 |
| MDR Report Key | 1561889 |
| Report Source | 06 |
| Date Received | 2009-12-10 |
| Date of Report | 2009-12-10 |
| Date of Event | 2009-11-12 |
| Date Mfgr Received | 2009-11-17 |
| Date Added to Maude | 2009-12-23 |
| 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 | LORI GATLEY-YAGER |
| Manufacturer Street | 525 FRENCH RD. |
| Manufacturer City | UTICA NY 13502 |
| Manufacturer Country | US |
| Manufacturer Postal | 13502 |
| Manufacturer Phone | 3156243403 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUREFIT |
| Generic Name | DISPERSIVE ELECTRODE |
| Product Code | ODR |
| Date Received | 2009-12-10 |
| Model Number | NA |
| Catalog Number | 410-2000 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORPORATION |
| Manufacturer Address | UTICA NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-12-10 |