MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2015-04-10 for LUMARX manufactured by Shaser, Inc.
[20366369]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[20461219]
Indication for use: removal of unwanted body and/or facial hair in adults with fitzpatrick skin types 1-4. User experienced what is likely permanent damage/scarring to her skin. User claims first and second degree burns have been diagnosed, although after several attempts, no medical records have been provided to confirm. Upon review of pictures provided by the user, it was clear that the user should not have passed the skin tone sensor which is a failsafe in the design that would turn the device off if skin tone was too dark. Additionally, skin tone charts are provided throughout the labeling and packaging of the device that would indicate that this person was too dark to use device. Although there was no opportunity to investigate the device in question within the 30 day reporting window, batch history records for the build demonstrate conformance with all safety and performance specifications, which would suggest the device and labeling would unlikely be the failure, rather use error.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009088196-2015-00001 |
| MDR Report Key | 4698852 |
| Report Source | 04 |
| Date Received | 2015-04-10 |
| Date Mfgr Received | 2015-03-04 |
| Device Manufacturer Date | 2014-12-01 |
| Date Added to Maude | 2015-04-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | CARL KAMMER |
| Manufacturer Street | 10 MAGUIRE ROAD BUILDING ONE |
| Manufacturer City | LEXINGTON MA 02421 |
| Manufacturer Country | US |
| Manufacturer Postal | 02421 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LUMARX |
| Generic Name | LIGHT BASED HAIR REMOVAL DEVICE |
| Product Code | ONF |
| Date Received | 2015-04-10 |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHASER, INC |
| Manufacturer Address | LEXINGTON MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-10 |