inforMED
MalfunctionFMC

NS-3600-B LITE GLOVE 1000/CASE

Received Jan 28, 2017

Report 9612030-2017-00042 · MDR key 6285097

Device

Generic name

Lite Glove

Manufacturer

Covidien

Model number

571711

Catalog number

571711

Product problems

  • Torn Material

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

SUBMIT DATE: 01/28/2017. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

Description of Event or Problem

IT WAS REPORTED TO COVIDIEN ON (B)(6) 2017 THAT AN ISSUE OCCURRED WITH A LITE GLOVE. THE CUSTOMER REPORTS THE LITE HANDLE COVER IS RIPPING WHEN PLACED ON LIGHT HANDLE.