MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-21 for FINESSE PATCH manufactured by Calibra Medical, Inc.
[22592869]
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. No conclusions can be made at this time.
Patient Sequence No: 1, Text Type: N, H10
[22592870]
On (b)(6) 2015, the reporter responded to an anonymous survey for calibra indicating that the patch ripped off going through a doorway. This complaint is being reported because the reported issue was not resolved. There was no indication that the product caused or contributed to an adverse event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008272700-2015-00026 |
| MDR Report Key | 4929694 |
| Date Received | 2015-07-21 |
| Date of Report | 2015-07-11 |
| Date Mfgr Received | 2015-07-11 |
| Date Added to Maude | 2015-07-21 |
| 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 | 0 |
| Brand Name | FINESSE PATCH |
| Generic Name | FINESSE INSULIN DELIVERYSYSTEM |
| Product Code | OPP |
| Date Received | 2015-07-21 |
| 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 | 2015-07-21 |