MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-11-28 for CLARITY MULTISTRIP UROCHECK US - 10SG US-100SG * manufactured by Rac Medical.
[420994]
`ptr has been using one bottle of clarity multistrip urocheck 10sg lot# 04825 expiration 10/2007 (the bottle contains the dessicant and is kept properly). Virtually every dipstick has shown a nitrite positive. When rptr compared this against a new bottle (same lot and expiration date), it is obvious that all of these nitrite results are false positive.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1037609 |
| MDR Report Key | 662186 |
| Date Received | 2005-11-28 |
| Date Added to Maude | 2006-01-12 |
| 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 |
| 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 | CLARITY MULTISTRIP UROCHECK US - 10SG |
| Generic Name | * |
| Product Code | JMT |
| Date Received | 2005-11-28 |
| Model Number | US-100SG |
| Catalog Number | * |
| Lot Number | 04825 |
| ID Number | * |
| Device Expiration Date | 2007-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 651596 |
| Manufacturer | RAC MEDICAL |
| Manufacturer Address | 141 NW 20TH ST BOCA RATON FL 33431 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-11-28 |