inforMED

G.E.D. DEVICE ELECTRIC SHOCK DEVICE

Received Aug 23, 1995

Report MW4000758 · MDR key 24869

Device

Generic name

Electric Shock Device

Product problems

  • Output, high

Patient

*

  • Burn(s)

Narrative

Description of Event or Problem

RPTR HAS RECEIVED SEVERAL REPORTS OF INCIDENTS INVOLVING UNINTENTIONAL DISCHARGES OF THE DEVICE WHICH RESIDENTS OF THE PROGRAM WEAR AND WHICH IS USED TO APPLY AN ELECTRIC SHOCK AS AVERSIVE TREATMENT. TWO OF THESE ALLEGATIONS HAVE BEEN INVESTIGATED, RESULTING IN CONCLUSIONS THAT, IN FACT, THE DEVICE HAD MISFIRED DUE TO A MALFUNCTION. BOTH INVESTIGATION CONCLUDED THAT THE RESIDENT WEARING THE DEVICE RECEIVED ELECTRICAL SHOCKS AS A RESULT OF THE MALFUNCTION. IN ONE OF THE CASES, THE SHOCKS WERE FOUND TO HAVE CAUSED TWO RING-SHAPED MARKS AND THREE AREAS OF ROUGH SKIN.