FDA Adverse Event
Injury
Summary report: N
NUPREP
MDR report key: 10132991
·
Received June 8, 2020
Report
- Report Number
- MW5094901
- Event Type
- Injury
- Date Received
- June 8, 2020
- Date of Event
- May 25, 2020
- Report Date
- June 5, 2020
- Manufacturer
- D. O. WEAVER AND COMPANY
- Product Code
- DRX
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
ON (B)(6) 2020 EEG PERFORMED FOR A RECORDING DURATION OF 20:06 MINUTES UTILIZING NUPREP 10/20 EEG PASTE AND GAUZE PADS. NO TAPE WAS USED. ON (B)(6) 2020 WOUND CARE REPORTED "MULTIPLE AREAS TO FOREHEAD WITH POSSIBLE BREAKDOWN FROM EEG PERFORMED SINCE ADMISSION DUE TO CHEMICAL BURNS"; 10/20 AN - AS NECESSARY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 590671 | NUPREP | ELECTRODE, ELECTROCARDIOGRAPH | DRX | D. O. WEAVER AND COMPANY |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR |