inforMED
MalfunctionFMC

NS-3600-B LITE GLOVE 1000/CASE

Received Nov 23, 2016

Report 9612030-2016-00717 · MDR key 6124659

Device

Generic name

Lite Glove

Manufacturer

Kenmex

Model number

571711

Catalog number

571711

Lot number

ASKU

Product problems

  • Break

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 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: BROKEN OR DAMAGED COMPONENT