MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-05-17 for STREP SELECT manufactured by Becton Dickinson Microbiology Systems.
[13672]
The first week the reporter started using this product, she noticed an unusual number were exhibiting no growth. She replated many of the culturettes the next day on a routine screening plate and found a lot were positive for group a strep. In one case, a 15-year-old was not initially treated and ended up being hospitalized. When he was replated heavy growth was found. Rptr feels this product is not as good as the routine blood auger. She has reported her concerns to the mfr and to the state health department.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1005957 |
| MDR Report Key | 21845 |
| Date Received | 1995-05-17 |
| Date of Report | 1995-04-20 |
| Date of Event | 1995-04-11 |
| Date Added to Maude | 1995-05-18 |
| 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 | MEDICAL TECHNOLOGIST |
| 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 | STREP SELECT |
| Generic Name | AUGER PLATE |
| Product Code | GTY |
| Date Received | 1995-05-17 |
| Lot Number | 21779, 21780 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 21906 |
| Manufacturer | BECTON DICKINSON MICROBIOLOGY SYSTEMS |
| Manufacturer Address | COCKEYSVILLE MD 21030 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1995-05-17 |