NEUROTECH KNEEHAB XP
Received Dec 9, 2015 · Event occurred May 5, 2015
Report 8020867-2015-00002 · MDR key 5276506
Device
Generic name
Powered Muscle Stimulator
Manufacturer
Bio-medical Research Ltd.Model number
412/421Catalog number
0421-5032
Lot number
1400420WE
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
87 YR
- Wound Dehiscence
Narrative
Additional Manufacturer Narrative
THE RETURNED DEVICE WAS FUNCTIONING AS EXPECTED. INSTRUCTIONS FOR USE NOT FOLLOWED . SECTION 2.2 PRECAUTIONS OF IFU , BULLET POINT 6, STATES, "CAUTION SHOULD BE USED IN THE PRESENCE OF THE FOLLOWING - FOLLOWING RECENT SURGICAL PROCEDURES WHEN MUSCLE CONTRACTION MAY DISRUPT THE HEALING PROCESS;" THIS PATIENT WAS USING THE DEVICE ON (B)(6) 2015 WHEN HE HAD SURGERY ON HIS KNEE ON (B)(6) 2015 WHICH IS 8 DAYS PREVIOUS.
Description of Event or Problem
PATIENT WAS PRESCRIBED THE LEFT KNEEHAB XP FROM HIS DOCTOR IN (B)(6) 2015. PATIENT ADVISED HE HAD KNEE SURGERY ON (B)(6) 2015 AND USED THE UNIT 1 DAY 05/05/15 X 3 TIMES. ALSO STATED THAT HE HAD A BANDAGE OVER THE WOUND BUT IT WAS NOT DIRECTLY UNDERNEATH THE KNEEHAB. THE THIRD TIME HE WENT TO USE IT HE WENT TO THE BATHROOM SHORTLY AFTERWARDS AND NOTICED BLOOD COMING DOWN HIS LEG. PATIENT CONTACTED HIS DOCTOR STRAIGHT AWAY. HE WAS ADVISED TO CEASE USING IT AND HE STATED USING THE KNEEHAB RESULTED IN HIS WOUND REOPENING AND HE NEEDED HIS DOCTOR TO RECLOSE THE WOUND.