inforMED
MalfunctionEYQ

FITRIGHT

Received Jul 1, 2026 · Event occurred Jun 3, 2026

Report 1417592-2026-03810 · MDR key 25684262

Device

Generic name

Underwear,protective,ultra,md,28-40

Catalog number

FIT23005A

Lot number

26052BL3

Product problems

  • Leak/Splash
  • Inadequacy of Device Shape and/or Size

Patient

NA · Male

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

IT WAS REPORTED THAT CUSTOMER CALLED IN STATING WHEN HE RECEIVED THE PRODUCT THEY ARE NOT VERY GOOD QUALITY MUCH THINNER THAN BEFORE. THE LEG ELASTIC AROUND THE LEGS IS ALSO VERY LOOSE AND CAUSING LEAKAGE.THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS IS A REPORTABLE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE REOPENED AND REEVALUATED.

Description of Event or Problem

IT WAS REPORTED THAT, CUSTOMER CALLED IN STATING WHEN HE RECEIVED THE PRODUCT THEY ARE NOT VERY GOOD QUALITY MUCH THINNER THAN BEFORE. THE LEG ELASTIC AROUND THE LEGS IS ALSO VERY LOOSE AND CAUSING LEAKAGE.