InjuryIPF

RICHMAR

Received Jun 1, 2010 · Event occurred Apr 14, 2010

Report MW5016151 · MDR key 1711466

Device

Generic name

Stimulator

Model number

AUTOSOUND 9.6

Lot number

UNK

Product problems

Insufficient Device Problem Information

Patient

Not reported

Erythema
Skin Irritation

Narrative

Description of Event or Problem

SMALL CIRCULAR REDDENED AREA THE SIZE OF A PENCIL ERASER HEAD WAS NOTED ON PT'S RIGHT LOW BACK PRIOR TO THE BEGINNING OF THE 10TH PHYSICAL THERAPY TREATMENT SESSION. SKIN INTEGRITY WAS INTACT WITHOUT OPEN SORE/WOUND. PT DID NOT VOICE COMPLAINT ABOUT SKIN INTEGRITY OR NOTICE REDDENED AREA ON RIGHT LOW BACK. PT WAS ADVISED TO RIGHT SKIN IRRITATION ON LOW BACK AND ADVISED TO MONITOR SKIN INTEGRITY.