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