MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-27 for FINESSE PATCH manufactured by Calibra Medical, Inc.
[71213729]
The lot number for this device was not provided and return is not expected as the product was discarded. No conclusions can be made at this time. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[71213730]
On 3/17/2017 it was reported that the patient developed a small, localized infection and was started on antibiotics; keflex 500 mg bid was prescribed. There was redness and soreness noted by the patient; a small amount of drainage was reported. At the same time, it was reported that the patient was not changing insertion sites at lease every 3 days. The patient was re-instructed to switch sites at least every 3 days and more often if necessary. Patch therapy was resumed according to the health care professional. This complaint is being reported because an adverse event due to use error was reported. There was no indication of a malfunction or defect.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008272700-2017-00007 |
| MDR Report Key | 6435846 |
| Date Received | 2017-03-27 |
| Date of Report | 2017-03-17 |
| Date Mfgr Received | 2017-03-17 |
| Date Added to Maude | 2017-03-27 |
| 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 | 0 |
| Brand Name | FINESSE PATCH |
| Generic Name | FINESSE INSULIN DELIVERYSYSTEM |
| Product Code | OPP |
| Date Received | 2017-03-27 |
| ID Number | 1-2VSIX7R |
| 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 | 965 CHESTERBROOK BLVD WAYNE PA 19087 US 19087 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-27 |