inforMED
InjuryIPG

MED/SURG SHOE

Received May 8, 1997 · Event occurred Mar 26, 1997

Report 2020737-1997-00001 · MDR key 90270

Device

Generic name

Foot Support

Model number

79-81135

Catalog number

79-81135

Lot number

NI

Patient

47 YR

Narrative

Description of Event or Problem

THE SUBJECT PATIENT ALLEGEDLY FELL AFTER A STRAP TAB ON THE SUBJECT FOOT SUPPORT (79-81135) BROKE APART. DURING THE FALL, THE PATIENT HIT HER SUTURED WOUND AGAINST A HARD SURFACE, WHICH RESULTED IN THE RE-OPENING OF THE WOUND. SURGICAL INTERVENTION WAS REQUIRED TO TREAT THE RE-OPENED WOUND.