DR COMFORT
Received Jul 1, 2014 · Event occurred Apr 1, 2014
Report 3010811527-2014-00001 · MDR key 3975148
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Tissue Damage
Narrative
Description of Event or Problem
COMPLAINT RECEIVED VIA COURT SUMMONS THAT ALLEGES "PATIENT SUFFERS FROM THE DISEASE OF DIABETES MELLITUS. ON THE FIRST DAY THAT THE PATIENT WORE THE DR. COMFORT BOOTS WHICH HE OBTAINED THRU TRUARCH, HE WAS SHOCKED TO LEARN THAT HE HAD DEVELOPED A SIGNIFICANT BLISTER ON HIS RIGHT HEEL. (B)(6) WAS UNAWARE OF THE DEVELOPMENT OF THIS BLISTER AS IT OCCURRED DUE TO THE FOOT NEUROPATHY FROM WHICH HE SUFFERS AS A RESULT OF HIS MEDICAL CONDITION. BECAUSE OF THE DEVELOPMENT OF THIS BLISTER AND ITS ENSUING CONSEQUENCES, (B)(6) WAS REQUIRED BY HIS TREATING PHYSICIANS TO ENDURE A LENGTHY HOSPITAL STAY AND CONTINUED WOUND CARE TREATMENT, AND WILL BE UNABLE TO WEAR A SHOE ON HIS RIGHT FOOT FOR AT LEAST A YEAR".