MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-07 for REMEL SABOURAUD DEXTROSE CONTACT PLATE R111105 manufactured by Remel Thermo Fisher Scientific.
[82452195]
Technician opened box of remel sab dex contact plates (product #r111105, lot #177380, exp #09/21/2017) to find one contaminated with profuse black growth. Reported to thermo fisher scientific.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5071455 |
| MDR Report Key | 6776817 |
| Date Received | 2017-08-07 |
| Date of Report | 2017-08-07 |
| Date of Event | 2017-08-07 |
| Date Added to Maude | 2017-08-09 |
| 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 | REMEL SABOURAUD DEXTROSE CONTACT PLATE |
| Generic Name | SABOURAUD DEXTROSE CONTACT PLATE |
| Product Code | JSG |
| Date Received | 2017-08-07 |
| Catalog Number | R111105 |
| Lot Number | 177380 |
| Device Expiration Date | 2017-09-21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2017-08-07 |