MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2012-12-05 for HI PWR DISPOSBL GRNDING PAD DGPHP manufactured by Covidien Lp.
[3370942]
The customer reported that following an rf ablation procedure when the four grounding pads were removed, a skin redness was noted at one pad site on the patient? S right thigh. A skin burn with blister was noted later that night. The injury was described as a 2nd degree burn and treated with ointment and daily cleaning.
Patient Sequence No: 1, Text Type: D, B5
[10395481]
(b)(4). To date, the incident sample has not been received for evaluation. If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted. Evaluation of the concomitant generator at the covidien (b)(4) service center found it to function normally and within specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2012-01209 |
| MDR Report Key | 2913823 |
| Report Source | 01,05,06 |
| Date Received | 2012-12-05 |
| Date of Report | 2012-11-12 |
| Date of Event | 2012-11-09 |
| Date Mfgr Received | 2012-11-12 |
| Date Added to Maude | 2013-03-11 |
| 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 | SHARON MURPHY - SR. DIRECTOR |
| Manufacturer Street | 5920 LONGBOW DR. |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 2034925267 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HI PWR DISPOSBL GRNDING PAD |
| Generic Name | RF ABLATION GROUNDING PAD |
| Product Code | ODR |
| Date Received | 2012-12-05 |
| Catalog Number | DGPHP |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LP |
| Manufacturer Address | 5920 LONGBOW DR. BOULDER CO 80301 US 80301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-12-05 |