MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-07-30 for AZO manufactured by Amerifit.
[672600]
In 2007, i purchased azo test strips for urinary tract infections to test on my daughter, she was running a temp and her doc thought she may have a uti. When i tested her urine it showed positive, so i took her to an after hours er when they tested her, it was negative. Which meant the azo test strip was wrong, once i got home, i used another test strip to check my own urine which also showed positive and i do not have a uti, so i had my husband use the third test strip to check his and low and behold his was also positive and he doesn't have a uti either. I feel this company has these test strips which show positive even when they should be negative so that consumers will go back and buy more of their products. Dates of use: one day in 2007. Diagnosis or reason for use: possible uti.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5003218 |
| MDR Report Key | 888616 |
| Date Received | 2007-07-30 |
| Date of Report | 2007-07-30 |
| Date of Event | 2007-07-27 |
| Date Added to Maude | 2007-08-08 |
| 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 | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AZO |
| Generic Name | TEST STRIPS |
| Product Code | JJW |
| Date Received | 2007-07-30 |
| Lot Number | 5L01E |
| Device Expiration Date | 2007-11-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 867156 |
| Manufacturer | AMERIFIT |
| Manufacturer Address | 166 HIGHLAND PARK DR BLOOMFIELD CT 06002 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-07-30 |