PROCARE
Received Dec 3, 2015 · Event occurred Oct 1, 2015
Report 9616086-2015-00031 · MDR key 5265397
Product problems
- Bent
- Component Missing
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Pressure Sore/Ulcer
Narrative
Additional Manufacturer Narrative
PRODUCT WAS RETURNED FOR REVIEW. ITEM IS NOT VERY USED, SIDE BARS ARE NOT ALIGNED ONE TO ANOTHER, DO NOT MATCH, ONE IS BENT A SIDE, ALSO IS MISSING A LOCKING KEY PIN ON RIGHT SIDE DORSI FLEXION ADJUSTMENT UNIT. SIDE BARS, THESE ARE LITTLE STIFF TO MOVE BACK AND FORWARD, NOT ALIGNED, VELCRO'S ARE GOOD. POSSIBLE ADJUSTMENT PROBLEMS.
Additional Manufacturer Narrative
NOT RETURNED FOR REVIEW.
Description of Event or Problem
PER 21CFR PART 803, AN MDR REPORTABLE EVENT. COMPLAINT RECEIVED VIA MEDWATCH (MW5057727) THAT ALLEGES "MALE ADMITTED ON (B)(6) 2015 SECONDARY 2 DEGREE TO DELIRIUM. ON (B)(6) 2015 STAFF NOTED CONCERN ON L MEDIAL MALLEOLUS. WOC APRN ASSESSED AND FOUND STAGE II HAPU LIKELY DUE TO CAM BOOT. PT ADMITTED WITH CAM BOOT. ON (B)(6) 2015, HAPU PROGRESSED TO STAGE III DUE TO INFECTION OF WOUND. CAM BOOT DISCONTINUED. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED; YES. DIAGNOSIS OR REASON FOR USE: DIABETIC FOOT W/POA WOUND". QUESTIONNAIRE WAS NOT RECEIVED FROM CLINICIAN AND/OR PATIENT. DEVICE NOT RETURNED TO MANUFACTURER FOR EVALUATION.