MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-03 for COOL SCULPTING FAT REDUCER manufactured by Zeltiq Aesthetics.
| Report Number | MW5089518 |
| MDR Report Key | 8960209 |
| Date Received | 2019-09-03 |
| Date of Report | 2019-08-29 |
| Date of Event | 2016-03-23 |
| Date Added to Maude | 2019-09-04 |
| 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 | COOL SCULPTING FAT REDUCER |
| Generic Name | DERMAL COOLING PACK / VACUUM MASSAGER |
| Product Code | OOK |
| Date Received | 2019-09-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZELTIQ AESTHETICS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2019-09-03 |