MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-11 for MIRADRY UNK manufactured by Sientra / Miradry, Inc..
Report Number | MW5090358 |
MDR Report Key | 9192096 |
Date Received | 2019-10-11 |
Date of Report | 2019-10-09 |
Date of Event | 2018-07-13 |
Date Added to Maude | 2019-10-15 |
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 | 0 |
Brand Name | MIRADRY |
Generic Name | INSTRUMENT FOR TREATMENT OF HYPERHIDROSIS |
Product Code | OUB |
Date Received | 2019-10-11 |
Model Number | UNK |
Catalog Number | UNK |
Lot Number | UNK |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | I |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | SIENTRA / MIRADRY, INC. |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Life Threatening; 2. Deathisabilit | 2019-10-11 |