MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2014-10-14 for HI PWR DISPOSBL GRNDING PAD DGPHP manufactured by Covidien Lp.
[5161799]
The customer reported that the patient received a 3rd degree burn at the pad site on the back of the right leg during an rf ablation procedure. The patient was repositioned during the procedure which ran 17 cycles from 9 am till 4 pm.
Patient Sequence No: 1, Text Type: D, B5
[12365101]
(b)(4). 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
[20327322]
The customer provided additional details regarding the procedure. During the procedure, the patient was moved once and ended up resting on her left side. No one checked the pads after the patient was repositioned. The surgeon cleaned the burned tissue from the wound and kept it open. The patient is being supplemented with protein to speed up the healing process and is still in icu. The incident pads were discarded by the site.
Patient Sequence No: 1, Text Type: D, B5
[20501371]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2014-00903 |
| MDR Report Key | 4170729 |
| Report Source | 01,08 |
| Date Received | 2014-10-14 |
| Date of Report | 2014-09-16 |
| Date of Event | 2014-08-18 |
| Date Mfgr Received | 2014-10-15 |
| Date Added to Maude | 2014-10-14 |
| 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 |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| 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 | 2014-10-14 |
| Model Number | DGPHP |
| Catalog Number | DGPHP |
| 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 DRIVE BOULDER CO 80301 US 80301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-10-14 |