FDA Adverse Event
Summary report: N
EKG PATCHES
MDR report key: 11385035
·
Received February 25, 2021
Report
- Report Number
- MW5099654
- Date Received
- February 25, 2021
- Date of Event
- February 5, 2021
- Report Date
- February 24, 2021
- Manufacturer
- CARDINAL HEALTH
- Product Code
- DRX
- Report Source
- Voluntary report
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
NEW EKG PATCHES PROVIDED TO THE LAB WERE USED DURING A STERILE PROCEDURE. THEY WERE NOT ADEQUATELY SHOWING EKG. STAFF HAD TO ENTER STERILE FIELD, RISKING CONTAMINATION, TO REPLACE ALL EKG PATCHES TO PROPERLY MONITOR THE PATIENT. COMPANY REP WAS CONTACTED AND ALTERNATE PRODUCT TO BE TRIALED. FDA SAFETY REPORT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 273789 | EKG PATCHES | ELECTRODE, ELECTROCARDIOGRAPH | DRX | CARDINAL HEALTH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR |