FDA Adverse Event
Summary report: N
CHOLESTRAK
MDR report key: 435523
·
Received November 18, 2002
Report
- Report Number
- MW4003414
- Date Received
- November 18, 2002
- Report Date
- November 18, 2002
- Manufacturer
- *
- Product Code
- CGO
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
THE COMPLAINANT REPORTED THAT THE KIT IS NOT SIMPLE TO USE. THEY DESCRIBED THAT WHEN USING THE PRODUCT TO PRICK FINGER FOR THE PLASTIC WELL TO TEST CHOLESTEROL, THE DEVICE REQUIRES MORE BLOOD. PT BELIEVES THAT WELL IS TOO LARGE AND ITS HARD GETTING ENOUGH BLOOD IN THE WELL TO RECEIVE A RESULT FROM TEST KIT. THE COMPLAINANT TRIED 4 TIMES BEFORE GETTING ENOUGH BLOOD TO SATISFY THE PLASTIC WELL AMOUNT TO RECEIVE RESULT FROM THE KIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CHOLESTRAK | CHOLESTEROL TEST KIT | CGO | * | NI | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO |