inforMED
MalfunctionFYA

MEDLINE

Received Jun 12, 2026 · Event occurred May 14, 2026

Report 1417592-2026-02445 · MDR key 25492816

Device

Generic name

Gown,sirus,polyrnf,setinslv,xl,20/cs

Catalog number

DYNJP2202S

Lot number

23326010005

Product problems

  • Appropriate Device Problem Term/Code Not Available

Patient

NA · Unknown

  • Insufficient Information

Narrative

Additional Manufacturer Narrative

IT WAS REPORTED THAT THEY HAVE BEEN COMPLAINING OF HAVING FLUID SEEP THROUGH THEIR SLEEVES, SO THEIR SKIN IS WET DURING THE CASE. 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 THEY HAVE BEEN COMPLAINING OF HAVING FLUID SEEP THROUGH THEIR SLEEVES, SO THEIR SKIN IS WET DURING THE CASE.