inforMED
MalfunctionOPJ

MEDLINE

Received Jul 1, 2026 · Event occurred Jun 5, 2026

Report 1417592-2026-03816 · MDR key 25681816

Device

Generic name

Glove,exam,pf,nitrile,smartbox,s

Catalog number

MDSXB7584

Lot number

CC509880491

Product problems

  • Material Split, Cut or Torn

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

IT WAS REPORTED BY THE CUSTOMER THAT THE GLOVES ARE RIPPING WHILE IN USE AND WHILE PUTTING ON. 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 BY THE CUSTOMER THAT THE GLOVES ARE RIPPING WHILE IN USE AND WHILE PUTTING ON.