inforMED
MalfunctionFMC

NS-3600-B LITE GLOVE 1000/CASE

Received Nov 14, 2016

Report 9612030-2016-00645 · MDR key 6099706

Device

Generic name

Lite Glove

Manufacturer

Covidien

Model number

571711

Catalog number

571711

Lot number

6179100064

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: 11/14/2016. 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) 2016 THAT A CUSTOMER HAD AN ISSUE WITH A LITE GLOVE. THE CUSTOMER REPORTS THAT THE LITE GLOVE SPLITS WHEN THE USER TRIES TO USE IT.