MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-07-24 for URS - 1K URINALYSIS STRIPS * manufactured by L.w. Scientific, Inc..
[293015]
Used urs -1k ketone strips while ill - strips gave a gray reading (not an optional color to detect ketones. ) parent given another bland (bayer) ketone strips.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1029068 |
| MDR Report Key | 473766 |
| Date Received | 2003-07-24 |
| Date of Report | 2003-07-14 |
| Date of Event | 2003-06-27 |
| Date Added to Maude | 2003-07-28 |
| 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 | RISK MANAGER |
| 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 | URS - 1K URINALYSIS STRIPS |
| Generic Name | URINE REAGENT STRIPS |
| Product Code | JJL |
| Date Received | 2003-07-24 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | D1006Z |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 462617 |
| Manufacturer | L.W. SCIENTIFIC, INC. |
| Manufacturer Address | * TUCKER GA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-07-24 |