MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-14 for COOLSCULPTING manufactured by Zeltiq Aesthetics Inc..
[175480660]
Had 5 treatments of coolsculpting done on abdomen. Product did nothing. Would like refund of half (b)(6) think that would be fair. Procedure done last summer around (b)(6) then back for more, 2 wks or month later. No results. Fda should not have cleared this device. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092229 |
| MDR Report Key | 9591510 |
| Date Received | 2020-01-14 |
| Date of Report | 2020-01-10 |
| Date Added to Maude | 2020-01-15 |
| 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 | 3 |
| Brand Name | COOLSCULPTING |
| Generic Name | DERMAL COOLING PACK / VACUUM / MASSAGER |
| Product Code | OOK |
| Date Received | 2020-01-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZELTIQ AESTHETICS INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-14 |