MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-16 for WHOLE BODY CRYOTHERAPY CHAMBER manufactured by Unk.
[124301969]
Reporter states that on (b)(6) 2018 she underwent cryotherapy to treat her stress and anxiety as well as to burn calories. The next day she experienced 2nd degree burns from the right side of her abdomen to her right thigh. She denies any other symptoms.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080617 |
| MDR Report Key | 7973607 |
| Date Received | 2018-10-16 |
| Date of Report | 2018-10-16 |
| Date of Event | 2018-09-30 |
| Date Added to Maude | 2018-10-17 |
| 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 | WHOLE BODY CRYOTHERAPY CHAMBER |
| Generic Name | BATH, HYDRO-MASSAGE |
| Product Code | ILJ |
| Date Received | 2018-10-16 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-10-16 |