inforMED
MalfunctionLEJ

SUNDASH

Received Apr 16, 2012 · Event occurred Mar 12, 2004

Report 2311923-2012-00012 · MDR key 2563075

Device

Generic name

Sundash Radiu 252

Catalog number

NA

Lot number

NA

Product problems

  • Nonstandard Device
  • Device Operates Differently Than Expected

Patient

Not reported

  • Injury

Narrative

Description of Event or Problem

CUSTOMER PLACED HER FINGER THROUGH FAN GRILL RESULTING IN INJURY TO FINGER.

Additional Manufacturer Narrative

UNIT DESIGN MEETS ALL FDA AND ET REQUIREMENTS FOR CONSUMER SAFETY. DEVICE HAS HANDLES FOR SUPPORT. NOT SURE WHY USER USED FAN GRILL FOR SUPPORT. FAN GRILL WAS ALTERED BY USERS OF THE DEVICE ALLOWING UNSUSPECTING CUSTOMER TO PASS FINGERS THROUGH GRILL AND REACH FAN BLADE RESULTING IN INJURY.

Remedial action

  • Recall