InjuryHBK

MAMMOGRAM MACHINE

Received May 31, 2006 · Event occurred Sep 29, 2005

Report MW1039397 · MDR key 726129

Device

Generic name

Sophie Classic Mobile

Manufacturer

Model number

Catalog number

Lot number

Product problems

Unknown (for use when the device problem is not known)

Patient

58 YR

Dural Tear

Narrative

Description of Event or Problem

PT HAD A MAMMOGRAM DONE IN 2005. WHEN THE TECH WAS REMOVING HER LEFT BREAST, UNDERNEATH THE MACHINE, HER TENDON AND SCAPULA WERE TORN DUE TO THE PRESSURE OF THE MACHINE. PT WILL HAVE SURGERY.