MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-01 for FINESSE PATCH manufactured by Calibra Medical, Inc.
[69018023]
Calibra requested return of the product but it has not been received. 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
[69018024]
On (b)(6) 2017, it was reported that the device? Kept falling off? So the patient placed tape over the patch to prevent this issue. There was no report of blood glucose excursion associated with this issue. This complaint is being reported as the issue may prevent use of device, or premature adhesive failure may cause patch to fall off,
Patient Sequence No: 1, Text Type: D, B5
[71523672]
Correct lot # for this complaint is 414.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008272700-2017-00002 |
| MDR Report Key | 6367689 |
| Date Received | 2017-03-01 |
| Date of Report | 2017-02-27 |
| Date Mfgr Received | 2017-02-27 |
| Date Added to Maude | 2017-03-01 |
| 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 | 3 |
| Brand Name | FINESSE PATCH |
| Generic Name | FINESSE INSULIN DELIVERYSYSTEM |
| Product Code | OPP |
| Date Received | 2017-03-01 |
| ID Number | 1-2VSIX7R |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| 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 | 2017-03-01 |