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 2010-05-05 for HI PWR DISPOSABLE GROUNDING PAD DGPHP manufactured by Covidien Lp (valleylab).
[21282195]
The customer reported that post-operatively to an rf ablation procedure, a burn was noted on the pt's right thigh where the grounding pad had been placed. The area was 10cm x 25cm and treated with cream. The burn was identified as 3rd degree based on a photograph of the injury provided by the customer.
Patient Sequence No: 1, Text Type: D, B5
[21433921]
(b) (4). To date, the incident sample has not been received for evaluation. If the sample is received, or if additional info pertinent to the incident is obtained, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2010-00306 |
| MDR Report Key | 1678908 |
| Report Source | 01,05,06 |
| Date Received | 2010-05-05 |
| Date of Report | 2010-04-05 |
| Date of Event | 2010-04-02 |
| Date Mfgr Received | 2010-04-05 |
| Date Added to Maude | 2010-05-12 |
| 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 | KIM SCHWARZ, MGR |
| Manufacturer Street | 5920 LONGBOW DR. |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 3035306245 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HI PWR DISPOSABLE GROUNDING PAD |
| Generic Name | RF ABLATION GROUNDING PAD |
| Product Code | ODR |
| Date Received | 2010-05-05 |
| 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 (VALLEYLAB) |
| Manufacturer Address | 5920 LONGBOW DR. BOULDER CO 80301 US 80301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-05-05 |