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 2013-10-01 for HI PWR DISPOSBL GRNDIG PAD DGPHP manufactured by Covidien Lp.
[3786429]
The customer reported that following an ablation procedure when the grounding pad was removed from the patient, a blister was noted at the pad site. The pad had been replaced on the back side of the patient's right thigh. The burn was described as 2cm x 2cm, 1st degree. No information was provided regarding treatment.
Patient Sequence No: 1, Text Type: D, B5
[11253492]
(b)(4). Date of initial report: 10/01/2013. The return of the incident sample has been requested. To date, it has not been received for evaluation. Additional questions in regard to the incident have been asked. If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2013-00781 |
| MDR Report Key | 3458171 |
| Report Source | 01,05,06 |
| Date Received | 2013-10-01 |
| Date of Report | 2013-09-04 |
| Date of Event | 2013-09-03 |
| Date Mfgr Received | 2013-09-04 |
| Device Manufacturer Date | 2011-10-01 |
| Date Added to Maude | 2014-01-07 |
| 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 | HI PWR DISPOSBL GRNDIG PAD |
| Generic Name | RF ABLATION GROUNDING PAD |
| Product Code | ODR |
| Date Received | 2013-10-01 |
| Catalog Number | DGPHP |
| Lot Number | 217699X |
| Device Expiration Date | 2014-10-31 |
| 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 | 2013-10-01 |