inforMED
MalfunctionFMC

3611 LITE GLOVE

Received Nov 23, 2016

Report 9612030-2016-00735 · MDR key 6124883

Device

Generic name

Lite Glove

Manufacturer

Covidien

Model number

31140208

Catalog number

31140208

Lot number

5278100464X

Product problems

  • Torn Material

Patient

Not reported

  • No Patient Involvement
  • No Patient Involvement

Narrative

Additional Manufacturer Narrative

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 TWO LITE GLOVES WERE FOUND TORN WHILE IN THE PACKAGING. NO PATIENT INVOLVED.