inforMED
MalfunctionFMC

3612 LITE GLOVE

Received Feb 6, 2017

Report 9612030-2017-00056 · MDR key 6303738

Device

Generic name

Lite Glove

Manufacturer

Covidien

Model number

31140257

Catalog number

31140257

Lot number

6160100464

Product problems

  • Hole In 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 UNDER WAY; 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 REPORTS THAT THERE ARE HOLES IN THE LITE GLOVES.