inforMED
MalfunctionOPH

ENCORE RADIATION ATTENUATION GLOVES

Received Jun 5, 2024 · Event occurred May 13, 2024

Report 19466401 · MDR key 19466401

Device

Generic name

Radiation Attenuating Medical Glove

Lot number

2306479504

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

OPENING RADIATION GLOVES FOR PROCEDURE AND OUTER PACKAGE DID NOT OPEN AS DESIGNED TO BE OPENED. THE PACKAGE TORE; ALMOST SHREDDING.