MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-17 for IRRADIATED TRYPTIC SOY AGAR WITH LECITHIN AND POLYSORBATE 80 BIOMERIEUX MEDIA TS M1060-IR manufactured by Biomerieux Inc..
[133829660]
Biomerieux plate (m1060-ir, tsa w/l&p80, lot# 1006837780, exp. 04/14/2019) had no inscription printed on it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083241 |
| MDR Report Key | 8261148 |
| Date Received | 2019-01-17 |
| Date of Report | 2019-01-16 |
| Date of Event | 2019-01-14 |
| Date Added to Maude | 2019-01-18 |
| 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 | 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 | 0 |
| Brand Name | IRRADIATED TRYPTIC SOY AGAR WITH LECITHIN AND POLYSORBATE 80 BIOMERIEUX MEDIA TS |
| Generic Name | CULTURE MEDIA NON-SELECTIVE AND NON-DIFFERENTIAL |
| Product Code | JSJ |
| Date Received | 2019-01-17 |
| Catalog Number | M1060-IR |
| Lot Number | 1006837780 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-17 |