inforMED
MalfunctionIOY

SUPPORT ARM 177

Received Jul 23, 2014 · Event occurred May 26, 2014

Report 8010042-2014-00268 · MDR key 4080314

Device

Catalog number

6481720

Product problems

  • Material Separation

Patient

Not reported

  • No Patient Involvement

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE SUPPORT ARM BROKE. THERE WAS NO PT INVOLVEMENT. (B)(4).

Additional Manufacturer Narrative

THE BROKEN PART HAS BEEN SENT BACK FOR INVESTIGATION. A SUPPLEMENTAL MEDWATCH WILL BE PROVIDED WHEN THE INVESTIGATION HAS BEEN FINALISED. (B)(4).