inforMED
MalfunctionFYA

MEDLINE

Received May 29, 2026 · Event occurred Apr 29, 2026

Report 1417592-2026-01900 · MDR key 25340665

Device

Generic name

Gown,sirus,polyrnf,raglan,l,st,32/cs

Catalog number

DYNJP2601

Lot number

212251000415

Product problems

  • Contamination

Patient

NA · Unknown

  • Insufficient Information

Narrative

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE HEART CENTER OR EXPERIENCED MEDLINE GOWN STRIKETHROUGH ISSUES THIS WEEKEND. DR. (B)(6) HAD A TOUGH CASE FRIDAY AND HE HAD MAJOR STRIKETHROUGH ON HIS LEGS. OVER THE WEEKEND, DR. (B)(6) HAD STRIKETHROUGH ON HIS SLEEVES, SO MUCH SO WHERE HE BROKE TO WASH HIS ARMS. 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 THE HEART CENTER OR EXPERIENCED MEDLINE GOWN STRIKETHROUGH ISSUES THIS WEEKEND. DR. (B)(6) HAD A TOUGH CASE FRIDAY AND HE HAD MAJOR STRIKETHROUGH ON HIS LEGS. OVER THE WEEKEND, DR. (B)(6) HAD STRIKETHROUGH ON HIS SLEEVES, SO MUCH SO WHERE HE BROKE TO WASH HIS ARMS.