MalfunctionIPG
PROCARE
Received Apr 21, 2016 · Event occurred Apr 5, 2016
Report 9616086-2016-00012 · MDR key 5595825
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
DEVICE NOT RETURNED.
Description of Event or Problem
COMPLAINT RECEIVED THAT ALLEGES "AFTER WEARING IT FOR 6 DAYS. PATIENT'S MOM STATES THAT THE RUBBER SOLE OF THE BOOT UNGLUED AND PT. TRIPPED ON IT AND FELL HITTING HER HEAD THIS MORNING. CLINIC STATES PATIENT DID NOT EXPERIENCE PAIN OR INJURY WHEN FALL OCCURRED". QUESTIONNAIRE NOT RECEIVED FROM CLINICIAN AND/OR PATIENT. DEVICE NOT RETURNED TO MANUFACTURER FOR EVALUATION. NO INDICATION EVENT CAUSED OR CONTRIBUTED TO PERMANENT IMPAIRMENT OR DEATH.