MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-07 for PED RETURN ELEC E751025 manufactured by Covidien Lp.
[33281743]
(b)(4). The incident grounding pad was discarded by the user and is not available for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[33281744]
The customer reported the rem pad was used during spinal surgery on a 15-20 lb male dog. The pad had been placed on the dog's abdomen. Upon removal, a little redness was noticed. It was identified as skin sensitivity. The patient was discharged home with owner. The owner returned 10 days later because the dog was burned in the shape of the rem pad. The wound was treated with antibacterial ointment. The vet reported the injury was a burn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1717344-2015-00877 |
| MDR Report Key | 5270371 |
| Date Received | 2015-12-07 |
| Date of Report | 2015-11-10 |
| Date Mfgr Received | 2015-11-10 |
| Date Added to Maude | 2015-12-07 |
| 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 | 3 |
| Event Location | 3 |
| 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 | 0 |
| Brand Name | PED RETURN ELEC |
| Generic Name | PATIENT GROUNDING PAD |
| Product Code | JOS |
| Date Received | 2015-12-07 |
| Model Number | E751025 |
| Catalog Number | E751025 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2015-12-07 |