MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-12 for MALT EXTRACT PLATE R01567 manufactured by Remel/thermo Fisher Scientific.
[80247210]
Technician opened new box of remel malt extract plates ((b)(4), lot# 169889, exp. 08/23/2017) and found one of the plates to contain a fragment of cardboard on/within agar.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5070994 |
| MDR Report Key | 6714029 |
| Date Received | 2017-07-12 |
| Date of Report | 2017-07-12 |
| Date of Event | 2017-07-10 |
| Date Added to Maude | 2017-07-14 |
| 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 | MALT EXTRACT PLATE |
| Generic Name | CULTURE MEDIA, NON SELECTIVE AND NON DIFFERENTIAL |
| Product Code | JSG |
| Date Received | 2017-07-12 |
| Catalog Number | R01567 |
| Lot Number | 169889 |
| Device Expiration Date | 2017-08-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | REMEL/THERMO FISHER SCIENTIFIC |
| Manufacturer Address | LENEXA KS 66215 US 66215 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-12 |