MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-03 for VALLEYLAB NON-REM POLYHESIVE PATIENT RETURN ELECTRODE E7506 manufactured by Covidien.
[89191540]
A 3 x 2. 6 x 0. 7 cm burn at the location of the patient return pad was found after the patient complained to his cardiologist upon a return visit after his initial surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6945509 |
| MDR Report Key | 6945509 |
| Date Received | 2017-10-03 |
| Date of Report | 2017-10-02 |
| Date of Event | 2017-06-28 |
| Date Facility Aware | 2017-08-07 |
| Report Date | 2017-10-02 |
| Date Reported to FDA | 2017-10-02 |
| Date Reported to Mfgr | 2017-10-03 |
| Date Added to Maude | 2017-10-12 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VALLEYLAB NON-REM POLYHESIVE PATIENT RETURN ELECTRODE |
| Generic Name | PATIENT RETURN ELECTRODE |
| Product Code | ODR |
| Date Received | 2017-10-03 |
| Catalog Number | E7506 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | MANSFIELD MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-10-03 |