MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-10 for NO NO HAIR manufactured by .
[28817369]
The no-no hair device left little brown dots on my legs and did not remove much hair. I called the company for a refund but had been away on vacation and the trial period had expired. I returned it and they sent me a new one. It did remove some of the hair on my legs but not as advertised and again more brown dots on my legs. I did not use it on my face as i did not want to be covered with brown dots. Was this device approved by the fda? When i asked to speak to a supervisor he was very rude. I did not see a physician or have any lab tests. Dates of use; 1 month. Event abated after use stopped or dose reduced; yes. Event reappeared after reintroduction; yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5057160 |
| MDR Report Key | 5161585 |
| Date Received | 2015-10-10 |
| Date of Report | 2015-10-10 |
| Date Added to Maude | 2015-10-20 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NO NO HAIR |
| Generic Name | HAIR REMOVAL DEVICE |
| Product Code | KCW |
| Date Received | 2015-10-10 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-10 |