MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-22 for manufactured by .
Report Number | COR18001661-000 |
MDR Report Key | 7997005 |
Date Received | 2018-10-22 |
Date of Report | 2018-10-22 |
Date Added to Maude | 2018-10-22 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 0 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Health Professional | 3 |
Initial Report to FDA | 0 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | Mrs Tammy Shiffler |
Manufacturer Street | 4321 Goshen Road |
Manufacturer City | Fort Wayne IN 46818 |
Manufacturer Country | US |
Manufacturer Postal | 46818 |
Manufacturer Phone | 8006542027 |
Manufacturer G1 | Young Innovations |
Manufacturer Street | 4321 Goshen Road |
Manufacturer City | Fort Wayne IN 46818 |
Manufacturer Country | US |
Manufacturer Postal Code | 46818 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Product Code | EHD |
Date Received | 2018-10-22 |
Device Availability | I |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2018-10-22 |