MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-28 for TT MICRO TEST KIT WITH FTM GROWTH MEDIA F-S005 AND F700 FF7S005 manufactured by Cultivate / Parasol Medical.
[177157939]
Growth media test kit noted to have expiration date of syringe that is different from date on package. Exp: 09/20/2020 is on packaging and 09/20/2019 is on syringe. Product not used, identified discrepancy in dating prior to use. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092617 |
| MDR Report Key | 9642527 |
| Date Received | 2020-01-28 |
| Date of Report | 2020-01-24 |
| Date Added to Maude | 2020-01-29 |
| 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 | 3 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TT MICRO TEST KIT WITH FTM GROWTH MEDIA |
| Generic Name | CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL |
| Product Code | JSJ |
| Date Received | 2020-01-28 |
| Model Number | F-S005 AND F700 |
| Catalog Number | FF7S005 |
| Lot Number | 20180920 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CULTIVATE / PARASOL MEDICAL |
| Manufacturer Address | CN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-28 |