MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-16 for FAT FREEZER manufactured by Beautyko, Llc.
[145495675]
Have 4 burns from using the fat freezer made by beautyko. No response from customer service. I emailed them to see if they thought it was defective since the burn from the square freezing panel is an oval about inch by 2 inches x 2 inch burns required special 3 wks of attention. I am a nurse so was able to buy special burn bandages to manage the burns. But now i have to deal with the scars. Fat freezer is a portable machine that freezes an area about 5x5 inches. It has a belt attachment and buttons for 30 min or 60 min of time. Mine is grey with a white front grill that has in an aqua color the words fat freezer.. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086707 |
| MDR Report Key | 8619978 |
| Date Received | 2019-05-16 |
| Date of Report | 2019-03-03 |
| Date of Event | 2019-01-13 |
| Date Added to Maude | 2019-05-17 |
| 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 | FAT FREEZER |
| Generic Name | DERMAL COOLING PACK, VACUUM MASSAGER |
| Product Code | OOK |
| Date Received | 2019-05-16 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BEAUTYKO, LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-16 |