MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-12-07 for CHOLESTRAK * manufactured by Accutech, Llc.
[383385]
This is not the first time store has expired products for sale. If one is not feeling well, one is not alert enough to notice these things.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1033964 |
| MDR Report Key | 562787 |
| Date Received | 2004-12-07 |
| Date of Report | 2004-11-18 |
| Date of Event | 2004-01-01 |
| Date Added to Maude | 2005-01-04 |
| 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 | 3 |
| 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 MEASURING DEVICE |
| Product Code | NFX |
| Date Received | 2004-12-07 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | UPC 7-8376280202 |
| ID Number | * |
| Device Expiration Date | 2002-08-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 552519 |
| Manufacturer | ACCUTECH, LLC |
| Manufacturer Address | 2641 LA MIRADA DRIVE VISTA CA 92081 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-12-07 |