MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-25 for FINESSE PATCH manufactured by Calibra Medical, Inc.
[36954455]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[36954456]
On (b)(6) 2016, it was reported that the patient inserted a device but on first use the buttons were locked and the device would not inject a dose of insulin. The patient confirmed that she filled the device and followed instructions correctly. The patient removed the device and inserted a new device. There was no indication that the product caused or contributed to an adverse event. This complaint is being reported because the device became unusable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008272700-2016-00005 |
| MDR Report Key | 5387740 |
| Date Received | 2016-01-25 |
| Date of Report | 2016-01-14 |
| Date Mfgr Received | 2016-01-14 |
| Date Added to Maude | 2016-01-25 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SAM CRAWFORD |
| Manufacturer Street | 220 SAGINAW DR |
| Manufacturer City | REDWOOD CITY CA 940634725 |
| Manufacturer Country | US |
| Manufacturer Postal | 940634725 |
| Manufacturer Phone | 6502984705 |
| Manufacturer G1 | CALIBRA MEDICAL, INC |
| Manufacturer Street | 220 SAGINAW DR |
| Manufacturer City | REDWOOD CITY CA 940634725 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 940634725 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FINESSE PATCH |
| Generic Name | FINESSE INSULIN DELIVERYSYSTEM |
| Product Code | OPP |
| Date Received | 2016-01-25 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | CALIBRA MEDICAL, INC |
| Manufacturer Address | 220 SAGINAW DR REDWOOD CITY CA 940634725 US 940634725 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-25 |