inforMED
MalfunctionFMC

NS-3631 N-STER DISPOSABLE

Received Nov 23, 2016

Report 9612030-2016-00709 · MDR key 6124584

Device

Generic name

Lite Glove

Manufacturer

Covidien

Model number

31159422

Catalog number

31159422

Product problems

  • Break

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 (B)(6) 2016 THAT A CUSTOMER HAD AN ISSUE WITH A LITE GLOVE. THE CUSTOMER REPORTS: BROKEN OR DAMAGED COMPONENT.