N
Patient 1
REFER TO ATTACHED REPORT FOR INVESTIGATION AND CORRECTIVE ACTION.
MAUDE MDR 5004152
- MDR report key
- 5004152
- Report number
- 2435501-2015-00001
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-07-15
- Date received
- 2015-08-12
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- KALMAN GROF-TISZA
- Address
- 115 TREE ST FLOWOOD MS 39232 US
- Phone
- 855-855-8558
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | DOVAC ELITE V2.0 | DOVAC ELITE V2.0 | IT SYNERGISTICS, LLC | MMH | NA | NA | NA | Y | * |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-08-12 | 0 |
Event Narratives#
D
Patient 1
THE DOVAC ELITE V2.0 SYSTEM ALLOWED THE TECHNICIAN REVIEW PROCESS TO BE COMPLETED FOR A FULL LENGTH DONOR HISTORY QUESTIONNAIRE (DHQ) WITHOUT OBTAINING A RESPONSE FOR A SINGLE QUESTION. REFER TO THE ATTACHED REPORT BEGINNING ON PAGE 4 FOR A COMPLETE INVESTIGATION AND CORRECTIVE ACTION COMPLETED.