FDA Adverse Event
Injury
Summary report: N
KLEARTRACE
MDR report key: 817327
·
Received February 7, 2007
Report
- Report Number
- 2244861-2007-00001
- Event Type
- Injury
- Date Received
- February 7, 2007
- Date of Event
- January 5, 2007
- Report Date
- February 7, 2007
- Manufacturer
- CAS MEDICAL SYSTEMS, INC.
- Product Code
- MLN
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ANOTHER DEVICE FROM LOT SENT TO BIOLOGICAL TESTING. NO RESULTS YET. MICROBIAL LIMITS AND BIOBURDEN LAB TESTING OF SIMILAR DEVICE FROM CUSTOMER'S STOCK OF SAME LOT.
Description of Event or Problem · 1
THE PT, IN ISOLATION FOR MRSA, IS REPORTED TO HAVE DEVELOPED PUSTULES, BURNS AND BLISTERS ON THE SKIN AT THE SITE OF THE ECG ELECTRODE, FIRST NOTICED WHEN THE ELECTRODE WAS REMOVED. IT WAS LATER REPORTED THAT THERE WAS NO PUS JUST FLUID FROM THE BLISTERS THAT ORIGINATED FROM REDNESS AT THE SITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KLEARTRACE | DISPOSABLE ECG NEONATAL ELECTRODE | MLN | CAS MEDICAL SYSTEMS, INC. | 4810 | 100907A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Required Intervention |