MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2015-07-15 for FINESSE PATCH manufactured by Calibra Medical, Inc.
[6009473]
On (b)(6) 2015, it was reported that the patient experienced "bubbling" at the patch insertion site. The patient noted that he went to the physician's office on the morning of (b)(6) 2015, and was told that there was an infection at the insertion site. He said that he was being treated with oral antibiotics. It is unknown if there was user error or malfunction. The patient declined to answer questions for customer support. This complaint is being reported for the following reason: the device may have caused or contributed to an alleged infection at the infusion site.
Patient Sequence No: 1, Text Type: D, B5
[14208175]
Calibra has been unable to request return of the product at this time. 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. T
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008272700-2015-00016 |
| MDR Report Key | 4915777 |
| Report Source | 04 |
| Date Received | 2015-07-15 |
| Date of Report | 2015-07-05 |
| Date Mfgr Received | 2015-07-05 |
| Date Added to Maude | 2015-07-15 |
| 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 | 0 |
| 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 94063472 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94063 4725 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FINESSE PATCH |
| Generic Name | FINESSE INSULIN DELIVERYSYSTEM |
| Product Code | OPP |
| Date Received | 2015-07-15 |
| 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 | 220 SAGINAW DR REDWOOD CITY CA 94063472 US 94063 4725 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-15 |