inforMED
InjuryKXG

HYDRAFLOCK

Received Jul 22, 2020 · Event occurred Jun 10, 2020

Report MW5095679 · MDR key 10312101

Device

Generic name

Applicator, Absorbent Tipped, Sterile

Product problems

  • Break

Patient

Not reported

  • Device Embedded In Tissue or Plaque
  • Device Embedded In Tissue or Plaque

Narrative

Description of Event or Problem

CALLER REPORTS THAT DURING A SAMPLE TESTING FOR COVID 19 USING HYDRAFLOCK NASAL SWAB, THE TIP OF THE SWAB BROKE OFF INSIDE THE PATIENT'S NARES AND THE PATIENT NEEDED SURGICAL INTERVENTION TO GET THE BROKEN PIECE OUT. REPORTER STATES "THE PATIENT WAS NERVOUS DURING THE SWAB TEST BUT THERE WAS ABSOLUTELY NO REASON FOR THE SWAB TO BREAK OFF". THE PATIENT IS DOING WELL AFTER SURGERY AND THE BROKEN PART WAS RECOVERED.