inforMED
MalfunctionFMC

NS-3600-B LITE GLOVE 1000/CASE

Received Sep 28, 2016

Report 9612030-2016-00477 · MDR key 5984545

Device

Generic name

Lite Glove

Manufacturer

Covidien

Model number

571711

Catalog number

571711

Lot number

6124112064

Product problems

  • Torn Material

Patient

Not reported

  • No Information
  • No Information

Narrative

Additional Manufacturer Narrative

SUBMIT DATE: 9/28/2016. AN INVESTIGATION IS CURRENTLY UNDER WAY; UPON COMPLETION THE RESULTS WILL BE FORWARDED.

Description of Event or Problem

IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT A CUSTOMER HAD AN ISSUE WITH A LITE GLOVE. THE CUSTOMER REPORTS THE LIGHT HANDLE COVER IS TEARING AT THE SEAM.