inforMED
MalfunctionIME

COLPAC

Received Oct 21, 2015 · Event occurred Sep 9, 2015

Report 5165017 · MDR key 5165017

Device

Generic name

Pack, Hot Or Cold, Reusable

Model number

35477

Lot number

14211010100

Product problems

  • Leak/Splash
  • Defective Device

Patient

Not reported

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

FOUR CERVICAL COLD PACKS ARE LEAKING. THEY WERE ACQUIRED APPROXIMATELY 3.5 MONTHS AGO. IT APPEARS WE MAY HAVE RECEIVED A DEFECTIVE LOT.