inforMED
MalfunctionKGO

MEDICHOICE POLYISOPRENE SURGICAL GLOVES (DISTRIBUTED BY OWENS AND MINOR)

Received May 7, 2021 · Event occurred Apr 20, 2021

Report 11789641 · MDR key 11789641

Device

Generic name

Surgeon's Gloves

Catalog number

SGL95085

Lot number

2010525704

Product problems

  • Material Integrity Problem

Patient

Not reported

  • Toxic Anterior Segment Syndrome (TASS)
  • Toxic Anterior Segment Syndrome (TASS)

Narrative

Description of Event or Problem

PATIENT UNDERWENT CATARACT SURGERY AND DEVELOPED TOXIC ANTERIOR SEGMENT SYNDROME (TASS) POST PROCEDURE. SURGICAL TECHNICIAN AND SURGEON NOTICED A DIFFERENCE IN TEXTURE OF THE SURGICAL GLOVES USED IN THIS PARTICULAR CASE. THE DIFFERENCE IN TEXTURE RAISED CONCERNS OF SURGICAL GLOVES POSSIBLY CONTAINING A POWDERED SUBSTANCE. THE GLOVES IN QUESTION ARE MEDICHOICE POLYISOPRENE SURGICAL GLOVES REF #SGL95085 WITH A LOT NUMBER 2010525704. ALL GLOVES WITH THIS SPECIFIC LOT NUMBER WERE PULLED FROM THE OPERATING ROOM AND ISOLATED.