N
Patient 1
THE PRODUCT HAS NOT BEEN RETURNED TO CALIBRA. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.
MAUDE MDR 4939648
- MDR report key
- 4939648
- Report number
- 3008272700-2015-00032
- Event key
- 0
- Event type
- 3
- Date received
- 2015-07-24
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 305
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- SAM CRAWFORD
- Address
- 220 SAGINAW DR REDWOOD CITY CA 94063 US
- Phone
- 650-650-6502
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | FINESSE PATCH | FINESSE INSULIN DELIVERYSYSTEM | CALIBRA MEDICAL, INC | OPP | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-07-24 | 0 |
Event Narratives#
D
Patient 1
ON (B)(6) 2015, THE PATIENT RESPONDED TO AN ANONYMOUS SURVEY FOR CALIBRA STATING THAT IT WAS DIFFICULT TO GET THE BUBBLES OUT OF THE PATCH. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.