N
Patient 1
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.
MAUDE MDR 9538907
- MDR report key
- 9538907
- Report number
- 1018233-2020-00002
- Event key
- 0
- Event type
- 3
- Date received
- 2020-01-02
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 401
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- YONIC ANDERSON
- Address
- 8195 INDUSTRIAL BLVD COVINGTON GA 30014 US
- Phone
- 770-770-7707
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SENSICA | SENSICA | ADAPTEC MEDICAL DEVICES LLC 3014271001 | EXS | SCCS1001 | NA | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-01-02 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THE SENSICA DEVICE WAS NOT ACCURATELY RECORDING VOLUME. THE COMPLAINANT NOTED THE DEVICE WAS 50-100 CC OFF OF THE ACCURATE READING EVERY HOUR.