MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2013-05-22 for RFA GROUNDING PAD RFAPAD manufactured by Covidien Lp.
[3547442]
The customer reported that following an ablation procedure, the pt complained of pain on the left thigh. A 2nd degree blister was noted at the pad site. The blister was suctioned and the tp status was good. The incident pad was discarded by the customer following the procedure and is not available for eval.
Patient Sequence No: 1, Text Type: D, B5
[10870934]
(b)(4). The incident sample was discarded by the site and is not available for eval. Add'l questions in regard to the incident have been asked. If add'l info pertinent to the incident is obtained, a f/u report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2013-00370 |
| MDR Report Key | 3170789 |
| Report Source | 01,05 |
| Date Received | 2013-05-22 |
| Date of Report | 2013-04-26 |
| Date of Event | 2013-04-25 |
| Date Mfgr Received | 2013-04-26 |
| Date Added to Maude | 2013-08-01 |
| 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. DIR. |
| 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 | RFA GROUNDING PAD |
| Generic Name | RF ABLATION GROUNDING PAD |
| Product Code | ODR |
| Date Received | 2013-05-22 |
| Catalog Number | RFAPAD |
| 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 | 2013-05-22 |