InjuryILY
INFRARED &LYMPHATIC DRAINAGE BODY WRAP
Received Mar 30, 2021 · Event occurred Mar 27, 2021
Report MW5100440 · MDR key 11596296
Device
Generic name
Lamp, Infrared, Therapeutic Heating
Manufacturer
UnkProduct problems
- Patient-Device Incompatibility
Patient
26 YR
- Bruise/Contusion
- Headache
- Numbness
- Bruise/Contusion
- Headache
- Numbness
Narrative
Description of Event or Problem
I BOUGHT A (B)(6) FOR A LYMPHATIC BODY WRAP AT (B)(6) WITH ESTHETICIAN (B)(6). AFTER WRAP WAS IN PLACE, I WAS LEFT UNATTENDED FOR ABOUT 25 MINUTES UNABLE TO MOVE AND CONTROL THE PRESSURE OF THE WRAP LEFT WITH SOME BRUISING AND NUMBING IN MY ARMS. WITH POST TINGLING AND HEADACHE. ESTHETICIAN SAID SHE WOULD GET THE MACHINE LOOKED AT AND POSTPONE APPOINTMENTS THAT DAY. FDA SAFETY REPORT ID# (B)(4).