MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,08 report with the FDA on 2010-01-25 for DISPERSIVE ELECTRODE 402-2204 manufactured by Conmed Corporation.
[1444517]
It was reported that "post-op the family noticed several small burns on the dorsal surface of the right hand of the pt. The pt was grounded on the right thigh. Pt is being treated with silvadene cream. "
Patient Sequence No: 1, Text Type: D, B5
[8490482]
We are attempting to gather add'l info regarding this incident. When the quality engineer has completed their investigation, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1320894-2010-00005 |
| MDR Report Key | 1591095 |
| Report Source | 07,08 |
| Date Received | 2010-01-25 |
| Date of Report | 2010-01-12 |
| Date of Event | 2009-12-15 |
| Date Mfgr Received | 2010-01-12 |
| Device Manufacturer Date | 2009-05-01 |
| Date Added to Maude | 2010-02-03 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | LORI GATLEY-YAGER, COORDINATOR |
| 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 | DISPERSIVE ELECTRODE |
| Generic Name | GROUND PAD |
| Product Code | ODR |
| Date Received | 2010-01-25 |
| Model Number | NA |
| Catalog Number | 402-2204 |
| Lot Number | 0905051 |
| 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 | 2010-01-25 |