MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-05 for FINESSE PATCH manufactured by Calibra Medical, Inc.
[72106146]
The device is not available for return to calibra for evaluation. No conclusions can be made at this time. Initial reporter: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[72106147]
On (b)(6) 2017 it was reported that the dosing buttons on the device were not functioning properly. The patient stated that the buttons do not lock, as expected, when the device is empty of insulin. There was no indication that the product caused or contributed to an adverse event. The complaint is being reported because the alleged malfunction has the ability to result in a delay in treatment or long term cessation in delivery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008272700-2017-00010 |
| MDR Report Key | 6460876 |
| Date Received | 2017-04-05 |
| Date of Report | 2017-03-23 |
| Date Mfgr Received | 2017-03-23 |
| Date Added to Maude | 2017-04-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 | KARIN SARGRAD |
| Manufacturer Street | 965 CHESTERBROOK BLVD |
| Manufacturer City | WAYNE PA 19087 |
| Manufacturer Country | US |
| Manufacturer Postal | 19087 |
| Manufacturer Phone | 4843561808 |
| Manufacturer G1 | CALIBRA MEDICAL, INC |
| Manufacturer Street | 965 CHESTERBROOK BLVD |
| Manufacturer City | WAYNE PA 19087 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19087 |
| 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 | 2017-04-05 |
| Lot Number | 400 |
| ID Number | 1-2VSIX7R |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CALIBRA MEDICAL, INC |
| Manufacturer Address | 965 CHESTERBROOK BLVD WAYNE PA 19087 US 19087 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-05 |