MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-11 for FINESSE PATCH manufactured by Calibra Medical, Inc.
[24064700]
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.
Patient Sequence No: 1, Text Type: N, H10
[24064701]
On (b)(6) 2015, it was reported that a patch came off after a shower. There was no adverse event reported. No additional information was provided related to the complaint as the information was provided through a survey. This complaint is being reported because the issue remains unresolved.
Patient Sequence No: 1, Text Type: D, B5
[27543521]
Follow up #1 submitted 08/26/2015: calibra received follow up from the patient on 08/19/2015. The patient indicated that the sites were prepared by washing the site but no alcohol wipes were used. The patient also indicated that hair was not removed from the site prior to application. The patient indicated that on one occasion the patch fell off after taking a shower, right after putting the patch on. This report is made under the requirements of the medical device reporting regulations and does not constitute an admission on the part of calibra of any deficiency in the performance of the device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008272700-2015-00038 |
| MDR Report Key | 4990588 |
| Date Received | 2015-08-11 |
| Date of Report | 2015-08-05 |
| Date Mfgr Received | 2015-08-05 |
| Date Added to Maude | 2015-08-11 |
| 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 |
| 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 | 2015-08-11 |
| 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 | 220 SAGINAW DR REDWOOD CITY CA 940634725 US 940634725 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-11 |