MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-30 for FINESSE PATCH manufactured by Calibra Medical, Inc.
[56551324]
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.
Patient Sequence No: 1, Text Type: N, H10
[56551325]
On (b)(6) 2016, the patient reported that the patch was caught on the edge of the counter. The device pulled off and could no longer be used. There was no indication that the product caused or contributed to an adverse event. This complaint is being reported because the device became unusable.
Patient Sequence No: 1, Text Type: D, B5
[60780950]
Follow up # 1 date of submission 11/9/2016 device evaluation: on 10/24/2016 the product analysis lab completed investigation of the returned device. Visual inspection was performed to evaluate the device. During inspection it was found that the device was used but not locked. Blood and hair was found at the adhesive patch. No physical or mechanical damages were found. Dhr review was performed and no issues related with the complaint were found. Based on the investigation and visual inspection results, it can be concluded that the complaint was not confirmed and no further action was required. According to the user's guide, the patient should avoid placing the patch where it will be frequently struck or rubbed against other objects. The user's guide precaution states: do not place the patch on sites that have significant body hair. Placing the patch onto sites with a significant amount of hair will reduce the adhesion of the patch, and will results in the patch detaching early. It is advised to remove body hair or to select an area that does not contain body hair.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008272700-2016-00030 |
| MDR Report Key | 5991928 |
| Date Received | 2016-09-30 |
| Date of Report | 2016-09-27 |
| Date Mfgr Received | 2016-09-27 |
| Date Added to Maude | 2016-09-30 |
| 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 | 2016-09-30 |
| Returned To Mfg | 2016-10-13 |
| ID Number | 1-2VSIX7R |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-09-30 |