MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-01-15 for THERMOGARD PLUS ABC 7-384 manufactured by Conmed Corp..
[1416160]
It was reported "our risk management committee was notified regarding an argon ground pad, (#7-384) that was removed and reapplied by the physician resulting in injury to a pt. The md and rn's involved were not aware that the grounding pads are not recommended for reapplication. "
Patient Sequence No: 1, Text Type: D, B5
[8508557]
The quality department was made aware of this incident on day 30 from the first date, a conmed employee had been made aware. Additional time was required to try to obtain additional info to make a determination of reportable. This info was just acquired. We acknowledge filing this report late. A supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1320208-2010-00001 |
| MDR Report Key | 1582780 |
| Report Source | 07 |
| Date Received | 2010-01-15 |
| Date of Report | 2010-01-15 |
| Date of Event | 2009-01-01 |
| Date Mfgr Received | 2009-12-09 |
| Date Added to Maude | 2010-01-25 |
| 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 |
| 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 | THERMOGARD PLUS ABC |
| Generic Name | DISPERSIVE ELECTRODE |
| Product Code | ODR |
| Date Received | 2010-01-15 |
| Model Number | NA |
| Catalog Number | 7-384 |
| 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 CORP. |
| Manufacturer Address | ROME NY 13440 US 13440 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-01-15 |