inforMED
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

Unk

Product 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).