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 2012-03-28 for HI POWER DISPOSABLE GROUNDING PAD DGPHP manufactured by Covidien Lp (valleylab).
[19595288]
(b)(4). The incident sample is not available for eval. If add'l info pertinent to the incident is obtained a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[19679164]
The customer reported that there was a case where a pt became burned at the return pad site. The area was reported to be blistered. The date of the event, degree of burn, type of treatment, and the pt gender and age are unk.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1717344-2012-00440 |
| MDR Report Key | 2524795 |
| Report Source | 01,05,06 |
| Date Received | 2012-03-28 |
| Date of Report | 2012-03-02 |
| Date Mfgr Received | 2012-03-02 |
| Date Added to Maude | 2012-09-06 |
| 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 POWER DISPOSABLE GROUNDING PAD |
| Generic Name | RF ABLATION GROUNDING PAD |
| Product Code | ODR |
| Date Received | 2012-03-28 |
| 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 | 2012-03-28 |