inforMED
MalfunctionFMC

NS-3600-B LITE GLOVE 1000/CASE

Received Jan 24, 2017 · Event occurred Dec 14, 2016

Report 9612030-2017-00034 · MDR key 6274562

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

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 A CUSTOMER HAD AN ISSUE WITH A LITE GLOVE. THE CUSTOMER STATES THAT THE LITE GLOVES WERE SPLIT OPEN AT THE CREASE.