inforMED
MalfunctionFMC

NS-3600-B LITE GLOVE 1000/CASE

Received Oct 3, 2016 · Event occurred Sep 27, 2016

Report 9612030-2016-00487 · MDR key 5995443

Device

Generic name

Lite Glove

Manufacturer

Covidien

Model number

571711

Catalog number

571711

Product problems

  • Material Integrity Problem

Patient

Not reported

  • No Patient Involvement
  • No Patient Involvement

Narrative

Additional Manufacturer Narrative

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 THEY ARE VERY FLIMSY AND THAT THEY ARE SPLITTING. THERE WAS NO PATIENT INVOLVED AND NO MEDICAL INTERVENTION.