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
Manufacturer
Medline Industries, LpCatalog 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.