inforMED
MalfunctionFMC

NS-3600-B LITE GLOVE 1000/CASE

Received Nov 23, 2016

Report 9612030-2016-00729 · MDR key 6124816

Device

Generic name

Lite Glove

Manufacturer

Kenmex

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:11/23/2016. AN INVESTIGATION IS CURRENTLY UNDER WAY. UPON COMPLETION THE RESULTS WILL BE FORWARDED.

Description of Event or Problem

IT WAS REPORTED TO COVIDIEN ON 10-26-2016 THAT A CUSTOMER HAD AN ISSUE WITH A LIGHT GLOVE. CUSTOMER REPORTS: TORN LIGHT HANDLE COVER.