FDA Adverse Event Injury Summary report: N

KNEEHAB XP

MDR report key: 12843964 · Received November 18, 2021

Report

Report Number
MW5105466
Event Type
Injury
Date Received
November 18, 2021
Date of Event
November 3, 2021
Report Date
November 17, 2021
Manufacturer
THERAGEN INC.
Product Code
IPF
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

I WAS PRESCRIBED A KNEEHAB DEVICE (HTTPS://WWW.KNEEHAB.COM/) ON (B)(6) 2021 AFTER MY RIGHT KNEE ACL AND MENISCUS SURGERY ON (B)(6) 2021. I DEVELOPED PAIN AND TENDINITIS IN MY RIGHT LOWER ADDUCTOR MUSCLES ON MY POST OP LEG AROUND (B)(6) 2021 USING THE KNEEHAB RELIGIOUSLY FOR A FEW WEEKS. THE PAIN IN MY RIGHT LOWER INNER THIGH, MEDIAL PART OF THE KNEE AND THE MEDIAL PART BELOW THE KNEE CREASE WAS MILD AT FIRST AND GOT PROGRESSIVELY WORSE AND BECAME SEVERE AROUND (B)(6) 2021. I HAD TO STOP ALL ACTIVITIES INCLUDING PHYSICAL THERAPY AND WALKING BECAUSE OF SEVERE PAIN. I HAD TO REST, ELEVATE, APPLY ICE AND VOLTAREN, MASSAGE THE AREA AND TAKE NSAIDS. SINCE I DID NOT SUSTAIN A SPRAIN OR ADDITIONAL PHYSICAL INJURY, THE ONLY POSSIBLE REASON I CAN THINK OF IS THAT VASTUS MEDIALIS OBLIQUE (VMO) LEAD OF THE KNEEHAB IS ALSO STIMULATING THE NEARBY ADDUCTORS BECAUSE THE CUFF AND LEADS ARE STILL TOO BIG FOR ME. I AM (B)(6) WOMAN WITH SIGNIFICANT POSTOP QUAD WASTING. THE KNEEHAB SLEEVE AND LEADS COME IN ONE SIZE ONLY AND SEEMS TO BE MADE FOR AVERAGE TO ATHLETIC MEN. THE ONLY ADJUSTMENT KNEEHAB OFFERS IS TO MOVE THE POSITION OF THE LEADS FOR SMALLER PEOPLE BUT THE ACTUAL CUFF SIZE AND LEAD SIZE STAYS THE SAME. IT IS MY BELIEF THAT THE LARGE KNEEHAB VMO LEAD ALSO OVERSTIMULATED MY LOWER ADDUCTOR MUSCLES AND TENDONS RESULTING IN PROGRESSIVE SEVERE PAIN AND TENDINITIS. (B)(6). FEEL FREE TO CONTACT ME AT (B)(6). FDA SAFETY REPORT ID# (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1734010 KNEEHAB XP STIMULATOR, MUSCLE, POWERED IPF THERAGEN INC. 2310-3310 T1900015CS

Patients

Seq Age Sex Outcome Treatment
1 57 YR Female Required Intervention| O JARDIANCE | METFORMIN