MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-08-10 for RPR ANTIGEN manufactured by Stanbio Corp..
[17772210]
The rptr stated that he is getting an unusual amount of false positive results. The rptr stated that this kit is not cost effective because he has to do 25 % more confirmation tests when using this product. He also stated that the material is very rough and it clogs the needles that are provided in the kit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1003053 |
| MDR Report Key | 15164 |
| Date Received | 1994-08-10 |
| Date of Report | 1994-08-10 |
| Date Added to Maude | 1994-08-11 |
| 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 |
| 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 | RPR ANTIGEN |
| Generic Name | DIAGNOSTIC KIT |
| Product Code | GMT |
| Date Received | 1994-08-10 |
| Lot Number | 2573104141 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 15157 |
| Manufacturer | STANBIO CORP. |
| Manufacturer Address | SAN ANTONIO TX 78202 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-08-10 |