MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-11-18 for CHOLESTRAK NI manufactured by *.
[15610524]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4003414 |
| MDR Report Key | 435523 |
| Date Received | 2002-11-18 |
| Date of Report | 2002-11-18 |
| Date Added to Maude | 2003-01-03 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHOLESTRAK |
| Generic Name | CHOLESTEROL TEST KIT |
| Product Code | CGO |
| Date Received | 2002-11-18 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NI |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 424444 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-11-18 |