MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-12 for LASER manufactured by .
[102365278]
On (b)(6) 2018 caller went to a laser store for a bikini hair removal. During the procedure, the caller felt pain and alerted. The technician who stated it is normal and continued with the procedure. At the end of the procedure caller was very sore and felt pain in the bikini area. She later discovered that she was badly burnt. She went to the emergency room for further treatment. (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075834 |
| MDR Report Key | 7334350 |
| Date Received | 2018-03-12 |
| Date of Report | 2018-03-12 |
| Date of Event | 2018-03-10 |
| Date Added to Maude | 2018-03-13 |
| 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 | 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 | LASER |
| Generic Name | LASER |
| Product Code | MWY |
| Date Received | 2018-03-12 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-03-12 |