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.
[71916813]
Calibra has been unable to be returned. No conclusions can be made at this time. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[71916814]
On (b)(6) 2017 it was reported that the needle of the device fell off when trying to insert it. There was no indication that the product caused or contributed to an adverse event. This complaint is being reported because long or short term cessation of insulin delivery may occur if patient is unable to use the device; the issue could signal that a foreign body may be stuck in site which may require medical intervention to remove.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008272700-2017-00008 |
| MDR Report Key | 6460496 |
| Date Received | 2017-04-05 |
| Date of Report | 2017-03-21 |
| Date Mfgr Received | 2017-03-21 |
| 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 | 040 |
| 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 |