MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-23 for HAIRMAX 12-V2 manufactured by Lexington Intl Llc.
[5861401]
Hair loss getting worse after using hairmax laser comb for 7 months which is completely different from what the company is claiming.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5043279 |
| MDR Report Key | 4875188 |
| Date Received | 2015-06-23 |
| Date of Report | 2015-03-23 |
| Date of Event | 2015-06-22 |
| Date Added to Maude | 2015-06-30 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HAIRMAX |
| Generic Name | LASER HAIR COMB |
| Product Code | OAP |
| Date Received | 2015-06-23 |
| Model Number | 12-V2 |
| Operator | LAY USER/PATIENT |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEXINGTON INTL LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-06-23 |