MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-08-08 for NUFACE NUFACE CLASSIC manufactured by Carol Cole Company.
[2202974]
Pt emailed corporate on (b)(6) 2011 and claimed "nuface broke all of the capillaries on my face. "he claimed he followed the instructions carefully, used it with other anti-aging serums, and had never experienced the issue before. He had already returned for refund to the retailer purchased on (b)(6) 2011. Device was tested when returned from retailer and no defects were found. Corporate instructed pt to consult a dermatologist to determine cause of broken capillaries. A letter was sent from the dermatologist on (b)(6) 2011 with the following notes: "a thorough exam yielded the following: red and blue fine telangiectasias scattered on his chest and face. Our impression: telangiectasias possibly caused by microcurrent device. Pt has no medical problem that would indicate that the telangiectasias are pathologic in nature. Recommendations and mgmt: (b)(6) is a good candidate for vbeam and electrodesiccation treatment. "
Patient Sequence No: 1, Text Type: D, B5
[9215886]
We were awaiting a confirmed diagnosis from the dermatologist who saw the subject.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006459199-2011-00001 |
| MDR Report Key | 2211411 |
| Report Source | 04 |
| Date Received | 2011-08-08 |
| Date of Report | 2011-08-08 |
| Date of Event | 2011-03-16 |
| Date Mfgr Received | 2010-04-05 |
| Device Manufacturer Date | 2010-04-01 |
| Date Added to Maude | 2011-08-25 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 3146 TIGER RUN COURT, STE. 109 |
| Manufacturer City | CARLSBAD CA 92010 |
| Manufacturer Country | US |
| Manufacturer Postal | 92010 |
| Manufacturer Phone | 7607344545 |
| Manufacturer G1 | QUALITY SYSTEMS INTEGRATED CORP. |
| Manufacturer Street | 5927 LANDAU COURT |
| Manufacturer City | CARLSBAD CA 92008 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92008 |
| Single Use | 0 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUFACE |
| Generic Name | NUFACE |
| Product Code | NFO |
| Date Received | 2011-08-08 |
| Returned To Mfg | 2011-04-27 |
| Model Number | NUFACE CLASSIC |
| Lot Number | INV000060670 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAROL COLE COMPANY |
| Manufacturer Address | CARLSBAD CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-08-08 |