MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-01 for FISHER DIAGNOSTICS TRUTOL GLUCOSE TOLERANCE TEST BEVERAGE 401272P manufactured by Fisher Diagnostics.
| Report Number | 1181121-2019-00001 |
| MDR Report Key | 9139107 |
| Date Received | 2019-10-01 |
| Date of Report | 2019-07-29 |
| Date of Event | 2019-04-18 |
| Report Date | 2019-06-20 |
| Date Reported to Mfgr | 2019-06-20 |
| Date Mfgr Received | 2019-07-12 |
| Device Manufacturer Date | 2018-12-19 |
| Date Added to Maude | 2019-10-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KYLE HOWARD |
| Manufacturer Street | 8365 VALLEY PIKE |
| Manufacturer City | MIDDLETOWN VA 22645 |
| Manufacturer Country | US |
| Manufacturer Postal | 22645 |
| Manufacturer Phone | 5408683655 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FISHER DIAGNOSTICS TRUTOL GLUCOSE TOLERANCE TEST BEVERAGE |
| Generic Name | DRINK, GLUCOSE TOLERANCE |
| Product Code | MRV |
| Date Received | 2019-10-01 |
| Catalog Number | 401272P |
| Lot Number | 440379 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 8 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FISHER DIAGNOSTICS |
| Manufacturer Address | 8365 VALLEY PIKE MIDDLETOWN VA 22645 US 22645 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-01 |