MalfunctionKME
MEDLINE
Received Jun 24, 2026 · Event occurred May 26, 2026
Report 1417592-2026-03008 · MDR key 25612488
Device
Product problems
- Material Integrity Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT UNDER PADS ARE NOT ABSORBING ENOUGH AND CAUSING LEAKAGE AND CAUSING HER BED TO GET WET. THERE ARE 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 UNDER PADS ARE NOT ABSORBING ENOUGH AND CAUSING LEAKAGE AND CAUSING HER BED TO GET WET.