inforMED
InjuryORZ

TEARCARE

Received May 26, 2022 · Event occurred Sep 27, 2021

Report MW5109964 · MDR key 14522235

Device

Generic name

Eyelid Thermal Pulsation System

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

Female

  • Fatigue
  • Rash
  • Arthralgia
  • Cough
  • Unspecified Eye / Vision Problem
  • Fatigue
  • Rash
  • Arthralgia
  • Cough
  • Unspecified Eye / Vision Problem

Narrative

Description of Event or Problem

PATIENT HAD A PROCEDURE ON A MACHINE CALLED TEARCARE AND HAD A SEVERE FACIAL RASH DEVELOP AND EYE ISSUES, AND THEN VERY SHORTLY AFTER HAD SYSTEMIC SYMPTOMS OF FATIGUE, COUGH, JOINT PAIN. FDA SAFETY REPORT ID # (B)(4).