inforMED
InjuryMAC

2% CHLORHEXIDINE GLUCONATE WIPES

Received Jul 31, 2019 · Event occurred Jul 24, 2019

Report MW5088642 · MDR key 8855342

Device

Generic name

Decontamination Kit

Manufacturer

Sage Products Llc

Product problems

  • Patient-Device Incompatibility

Patient

67 YR

  • Headache
  • Hypersensitivity/Allergic reaction
  • Rash
  • Vomiting
  • Headache
  • Hypersensitivity/Allergic reaction
  • Rash
  • Vomiting

Narrative

Description of Event or Problem

PT CALLED TO REPORT AN ADVERSE REACTION TO A WIPE THAT WAS USED ON HER BEFORE AN OUTPATIENT SURGERY. PT STATED THAT SHE HAD AN ALLERGIC REACTION AND BROKE OUT INTO HIVES. ALTHOUGH SHE WAS WIPED DOWN AFTER USE, THE PT CONTINUED TO EXPERIENCE VOMITING, DRY HEAVES, AND PROLONGED HEADACHE. THE PT STATED SHE FEELS SHE WAS POISONED, AND THAT THIS DEVICE COULD BE DANGEROUS IF APPLIED INDISCRIMINATELY. PT STATED SHE FEELS A PATCH TEST SHOULD BE DONE BEFORE USE. PT SAID HER SYMPTOMS DID NOT RESOLVE UNTIL SHE TOOK A BATH.