MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-06 for I GROW HAIR GROWTH SYSTEM manufactured by Apira Science.
[69479508]
On both occasions, i used device. After a couple of days redness appears, then itching, flaking. Note: i contacted the company after first incident. They told me that the unit could not have caused it, as it uses cold lasers. I then repeated using with same result on (b)(6) 2017. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[74610710]
Additional info received from reporter for report mw5068341 on (b)(6) 2017. This is an update to a letter i sent you dated (b)(6). It included a form 3500 i submitting regarding an adverse event with the hair laser product igrow and photos of my face. At the time i wrote you, i thought that the unit had burned me, twice. I am writing to revise my statement of facts about the problem. I continue to have redness and faking in the areas that i wrote about previously. I am now being treated for seborrheic keratosis. It appears to my physician that the unit may have, in some way, triggered this condition. I had acute occurrences each time i use it. The first time was on (b)(6), before i headed back east. After the company assured me that the unit could not cause burns, i tried it again on (b)(6) or so. Again, a few days later, redness appeared, this time on my left elbow and eyelid. I asked my physician if he thought these were connected or random events - use of the unit and development of skin condition. He said he remains suspicious that there may be a connection because i developed it at the times of using the unit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5068341 |
| MDR Report Key | 6386916 |
| Date Received | 2017-03-06 |
| Date of Report | 2017-02-27 |
| Date of Event | 2017-01-15 |
| Date Added to Maude | 2017-03-08 |
| 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 | 3 |
| Brand Name | I GROW HAIR GROWTH SYSTEM |
| Generic Name | I GROW HAIR GROWTH SYSTEM |
| Product Code | OAP |
| Date Received | 2017-03-06 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APIRA SCIENCE |
| Manufacturer Address | 1200 N. FEDERAL HWY BOCA RATON FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-03-06 |