MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a study report with the FDA on 2015-10-14 for FINESSE PATCH manufactured by Calibra Medical, Inc.
[28241903]
The product has not been returned to calibra. If the device is returned, an evaluation shall be completed and a supplemental report will be filed. Calibra performed a lot review of the product distributed during the study and confirmed that the lots were within specifications at the time of release. No conclusions can be made at this time.
Patient Sequence No: 1, Text Type: N, H10
[28241904]
On (b)(6) 2015, the patient responded to an anonymous survey for calibra that the first time the device was inserted, the patient had an infection. On (b)(6) 2015, calibra received the results of the exit interview with the study participant indicating that the infection required a prescribed antibiotic. The participant indicated that the lump at the site remained for quite a while. This report is made based on the indication obtained on (b)(6) 2015 that the patient's infection with use of the product required prescribed antibiotics.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008272700-2015-00048 |
| MDR Report Key | 5148745 |
| Report Source | STUDY |
| Date Received | 2015-10-14 |
| Date of Report | 2015-09-21 |
| Date Mfgr Received | 2015-09-21 |
| Date Added to Maude | 2015-10-14 |
| 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 | 2015-10-14 |
| 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 | 1. Life Threatening | 2015-10-14 |