InjuryFMP
DR COMFORT
Received Mar 26, 2015
Report 3010811527-2015-00001 · MDR key 4641425
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
PER 21 CFR PART 803, AN MDR REPORTABLE EVENT. COMPLAINT RECEIVED FROM CLINICIAN THAT ALLEGES "SHOE BOTHERED PATIENTS BUNION AND AS A RESULT, HIS TOE WAS REMOVED A FEW WEEKS AGO." QUESTIONNAIRE WAS NOT RECEIVED FROM CLINICIAN AND/OR PATIENT. DEVICE NOT RETURNED TO MANUFACTURER FOR EVALUATION.