MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-09-06 for HAIRMAX LASER COMB manufactured by .
[3869012]
Pt started using the lasercomb late (b)(6) 2012 for thinning hair. Within 2 weeks she was having tingling in her scalp and pain. After 3 months of product use she discovered that the lasercomb was the causative agent. She discontinued use and within 2 weeks the pain ceased. She then attempted to utilize the product for a second time. After using the device 3 times a week, the pain and tingling returned. After 5 months the pt stopped using the product but continued having pain (tremendous) and tingling to the scalp. The neurologist stated that the pain may be product use related.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5031744 |
| MDR Report Key | 3339324 |
| Date Received | 2013-09-06 |
| Date of Report | 2013-09-06 |
| Date of Event | 2013-01-11 |
| Date Added to Maude | 2013-09-11 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HAIRMAX LASER COMB |
| Generic Name | LASERCOMB |
| Product Code | OAP |
| Date Received | 2013-09-06 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-06 |