MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-15 for HEMAPROMPT FG manufactured by Aerscher Diagnostics.
[49663722]
Patient Sequence No: 1, Text Type: N, H10
[49663723]
Ed manager reported that the hemaprompt fg screening test kits are dried out and not usable. They are given to a patient to do a fecal and gastric occult blood screen.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5797728 |
| MDR Report Key | 5797728 |
| Date Received | 2016-07-15 |
| Date of Report | 2016-07-13 |
| Date of Event | 2016-07-12 |
| Report Date | 2016-07-13 |
| Date Reported to FDA | 2016-07-13 |
| Date Reported to Mfgr | 2016-07-13 |
| Date Added to Maude | 2016-07-15 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | HEMAPROMPT FG |
| Generic Name | REAGENT, OCCULT BLOOD |
| Product Code | KHE |
| Date Received | 2016-07-15 |
| Lot Number | 967 |
| ID Number | PATENT 5171529 |
| Device Expiration Date | 2016-08-31 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AERSCHER DIAGNOSTICS |
| Manufacturer Address | 125 DIXON DRIVE CHESTERTOWN MD 21620 US 21620 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-15 |