inforMED
MalfunctionLZA

POLYMER PATIENT EXAMINATION GLOVE

Received Jul 22, 2021 · Event occurred May 11, 2021

Report 12210524 · MDR key 12210524

Device

Generic name

Polymer Patient Examination Glove

Model number

20687280

Lot number

2002042905

Product problems

  • Product Quality Problem
  • Tear, Rip or Hole in Device Packaging

Patient

Not reported

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

Narrative

Description of Event or Problem

ANSELL SURGICAL GLOVES ARE RIPPING WHEN CLINICIANS ARE DONNING. MANUFACTURER RESPONSE FOR SURGICAL GLOVES, (BRAND NOT PROVIDED) (PER SITE REPORTER): THEY PERFORMED AN INVESTIGATION, IDENTIFIED THE ROOT CAUSE, AND IMPLEMENTED A CORRECTIVE ACTION.