InjuryLPQ

EXOGEN

Received Mar 18, 2010 · Event occurred Feb 18, 2010

Report 1020279-2010-00079 · MDR key 1635390

Device

Generic name

Bone Healing System / Lpq

Manufacturer

Brooks Manufacturing Site

Model number

EXOGEN 4000+MOU

Catalog number

71034101

Lot number

Product problems

Insufficient Device Problem Information

Patient

53 YR

Skin Discoloration
Tissue Damage

Narrative

Description of Event or Problem

APPROXIMATELY 3 MONTHS AGO, PATIENT UNDERWENT LEFT WRIST SURGERY AND TREATMENT WITH THE EXOGEN DEVICE. AFTER THE REMOVAL OF THE CAST, PATIENT NOTICED A SKIN DISCOLORATION AND AN OPEN WOUND AREA ON THE TREATMENT SITE.