MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-07-18 for NITRATEST PAPER 00003-0526-50 manufactured by Bristol-myers Squibb Company.
[17975087]
Labor and delivery nurse reports multiple false negative results. My fear is that prior to receipt, these products may have been exposed to/stored at excessive high temperatures due to the current season.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5021457 |
| MDR Report Key | 2175256 |
| Date Received | 2011-07-18 |
| Date of Report | 2011-07-18 |
| Date of Event | 2011-07-18 |
| Date Added to Maude | 2011-07-29 |
| 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 | PHARMACIST |
| 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 | NITRATEST PAPER |
| Generic Name | PHENAPHTHAZINE PAPER |
| Product Code | HIO |
| Date Received | 2011-07-18 |
| Catalog Number | 00003-0526-50 |
| Lot Number | 8F4601BS |
| ID Number | 00003-0526-50 |
| Device Expiration Date | 2013-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BRISTOL-MYERS SQUIBB COMPANY |
| Manufacturer Address | PRINCETON NJ 08543 US 08543 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-07-18 |