MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,study report with the FDA on 2016-08-29 for FINESSE PATCH manufactured by Calibra Medical, Inc.
[53374443]
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. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[53374444]
On (b)(6) 2016, it was reported that the infusion site was possibly infected and was treated by a health care professional. It was said that there was pain after insertion, that the patient continued to wear the patch for 2 days, and there was bleeding and swelling around the area of insertion. The hcp evaluated the site and determined that it was a possible infection due to the insertion possibly hitting a blood vessel. An oral antibiotic was prescribed for 10 days. No further information has been received. The device was discarded by the patient and no lot number was made available. No information about other sources of infection were explored (site preparation, for example). The complaint is being reported because the patient required medical intervention to treat a possible infection that may have been caused or contributed to by the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008272700-2016-00025 |
| MDR Report Key | 5910561 |
| Report Source | CONSUMER,STUDY |
| Date Received | 2016-08-29 |
| Date of Report | 2016-08-19 |
| Date Mfgr Received | 2016-08-19 |
| Date Added to Maude | 2016-08-29 |
| 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 | 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 | 3 |
| Brand Name | FINESSE PATCH |
| Generic Name | FINESSE INSULIN DELIVERYSYSTEM |
| Product Code | OPP |
| Date Received | 2016-08-29 |
| 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 | 220 SAGINAW DR REDWOOD CITY CA 940634725 US 940634725 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-29 |