MalfunctionIME

PACK, HOT OR COLD, REUSEABLE

Received Aug 8, 2016 · Event occurred Jul 13, 2016

Report 5852938 · MDR key 5852938

Device

Generic name

Pack, Hot Or Cold, Reuseable

Manufacturer

Polar Products Inc.

Product problems

Defective Component
Moisture or Humidity Problem

Patient

Not reported

No Known Impact Or Consequence To Patient
No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

WETNESS NOTICED ON TOP OF KNEE BETWEEN ICE PACK AND ACE BANDAGE. MANUFACTURER RESPONSE FOR POLAR ICE PACK, (BRAND NOT PROVIDED) (PER SITE REPORTER): WILL COMMUNICATE ISSUE TO INTERNAL QUALITY; DEFECTIVE PRODUCT NOT KEPT BY HOSPITAL TO GIVE TO SUPPLIER SO SUPPLIER UNABLE TO PERFORM QUALITY CHECKS.