inforMED
InjuryIQI

CUSTOM ORTHOTICS

Received Jan 22, 2025 · Event occurred Sep 4, 2024

Report MW5165135 · MDR key 21219206

Device

Generic name

Orthosis, Limb Brace

Model number

804010

Patient

62 YR · Female

  • Pain
  • Pain

Narrative

Description of Event or Problem

I HAVE BEEN FOLLOWED AS A PATIENT WITH A ANKLE/FOOT PROBLEM BY DR. (B)(6). CUSTOM ORTHOTICS WERE MADE THROUGH (B)(6). THE INITIAL SET OF ORTHOTICS WAS MADE CAUSE MY FOOT TO OVER PRONATE LEADING TO SEVERE PAIN AND DID NOT SUPPORT THE BUNION CAUSING INCREASE PAIN. A REPEAT VISIT TO THE DR.'S OFFICE LED TO A REVISION IN THE ORTHOTICS, THE FIRST SET WAS WORSE THAN THE SECOND SET. A REPEAT VISIT TO THE DR. LED TO A THIRD REVISION OF THE ORTHOTICS, WITH LITTLE TO NO IMPROVEMENT. THE ORTHOTICS ARE CHEAPLY MADE AND ARE NOT CUSTOM. I HAVE SUFFERED MORE PAIN IN MY FOOT ANKLE WITH THESE ORTHOTICS THAN PREVIOUS CUSTOM ORTHOTICS. I HAVE ATTEMPTED TO CONTACT THE COMPANY, BUT THE ARE EVASIVE AND NOT WILLING TO REFUND MONEY SPENT OR BACK THE PRODUCT OR WARRANTY. REFERENCE REPORTS: MW5165136, MW5165137.