MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-12-05 for SELECTIVE STREP THROAT CULTURE P 1640 * manufactured by Northeast Lab. Svcs..
[113440]
Medium is too thin. When incubated at proper temperature it turns brown, won't support growth. Problem was reported to the mfr but firm was unconcerned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1012615 |
| MDR Report Key | 136823 |
| Date Received | 1997-12-05 |
| Date of Report | 1997-12-05 |
| Date of Event | 1997-12-01 |
| Date Added to Maude | 1997-12-10 |
| 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 | SELECTIVE STREP THROAT CULTURE |
| Generic Name | AGAR PLATE |
| Product Code | JSI |
| Date Received | 1997-12-05 |
| Model Number | P 1640 |
| Catalog Number | * |
| Lot Number | 9146 |
| ID Number | * |
| Device Expiration Date | 1998-01-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 133657 |
| Manufacturer | NORTHEAST LAB. SVCS. |
| Manufacturer Address | CHINA RD. WINSLOW ME 04901 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-12-05 |