DR. SCHOLL'S MASSAGING GEL HEEL CUPS
Received Jul 14, 2010
Report 1031623-2010-00001 · MDR key 1883098
Device
Generic name
Orthosis, Corrective Shoe
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Unspecified Infection
- Tissue Damage
Narrative
Description of Event or Problem
A (B)(4) SERIOUS DEVICE REPORT WAS RECEIVED BY A COMPANY REPRESENTATIVE REGARDING A MALE CONSUMER. CONCOMITANT MEDICATIONS WERE UNKNOWN. MEDICAL HISTORY WAS NOT PROVIDED. THE COMPANY REPRESENTATIVE REPORTED THE CONSUMER'S WIFE HAD SPOKEN TO THE COMPANY REPRESENTATIVE'S WIFE AND STATED THE CONSUMER HAD USED (B)(4) MASSAGING GEL HEEL CUPS. FREQUENTLY OF USE AND INDICATION FOR PRODUCT USE WERE NOT PROVIDED. THE COMPANY REPRESENTATIVE STATED HE "GUESSED" THE PRODUCT HAD "CAUSED SOME BLISTER ON HIS FOOT" WHICH "BECAME INFECTED". HE ADDITIONALLY STATED THE CONSUMER EVENTUALLY HAD A TOE AMPUTATED. THE COMPANY REPRESENTATIVE WAS NOT SURE IF THIS WAS A DIRECT CAUSE AND EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).