MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-26 for MIRADRY manufactured by Miradry, Inc..
[181647248]
Greetings, i'm writing to complain about a problem that seriously affects an individual's social life and work, caused by miradry treatment. Miradry causes an increase in bad smell of sweat in the armpit for many people. I had miradry treatment in (b)(6) 2016, the smell of armpit became very bad. I contacted miradry company, but they did not provide me with any info about the reason for this problem and how to solve it, also i contacted the dr in (b)(6), but had no info about the reason as well, and then i found that many of those who performed this treatment had the same problem. Please see cases of people who complain of the same problem in (b)(6). Please do the required action in such cases, and please help me to get the solution from miradry company. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093314 |
| MDR Report Key | 9763577 |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-24 |
| Date of Event | 2016-08-01 |
| Date Added to Maude | 2020-02-27 |
| 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 | MIRADRY |
| Generic Name | INSTRUMENT FOR TREATMENT OF HYPERHIDROSIS |
| Product Code | OUB |
| Date Received | 2020-02-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIRADRY, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-26 |