MAUDE Adverse Event Report: MEDI-DYNE HEALTHCARE PRODUCTS CHO-PAT ORIGINAL KNEE STRAP

Model Number 420MM LONG AND 50 MM WIDE BAND

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Emotional Changes (1831); Fall (1848); Bone Fracture(s) (1870); Pain (1994); Ambulation Difficulties (2544)

Event Date 05/22/2013

Event Type  Injury  

Event Description

This is the information i submitted electronically via their website to medi-dyne healthcare products, (b)(4): hello i am contacting you due to the fracture of the right patella that i sustained on (b)(6) 2013 whilst wearing the cho-pat original knee strap.(b)(4) or medica surgical innovations contacted you in the summer of 2013 on behalf of the (b)(6) and at that time you indicated that the band submitted by (b)(4) (a 420 mm long and 50 mm wide fabric bank with velcro at each end wrapped and stitched around a high density foam tube) showed very little signs of use in general and that the device showed no signs of failure whatsoever and was indeed to your specification.This was not a surprising finding since the device was new and i had only worn it for two days before sustaining a complete horizontal fracture of my right patella in a fall.This fall occurred while out walking and slipping on gravel on a gentle slope.As a result of this slip, i fell backwards, ending up unexpectedly sitting on the ground.There was no direct impact on the kneecap itself.My knee injury necessitated surgery to repair the break with metalwork (two screws and a wire), immobilisation within a brace for six weeks as well as months of physiotherapy and rehabilitation.I have just recently also had further surgery to remove the metalwork.All in all, this incident was extremely traumatic and resulted in a temporary loss of independence, pain and emotional suffering, expense and the inability to work in my usual way.If i would be self-employed, particularly in a physically demanding job, it could have had a very detrimental effect on my earnings.My motivation in contacting you is to raise the possibility of whether this fabric band may have been a contributing factor in the patella fracture.In (b)(6) 2013 i had been having some pain in my right knee, and the physiotherapist i consulted on (b)(6) recommended this band.I acknowledge that i may have had an undiagnosed hairline fracture of the patella when i started to wear this band (although an x-ray had not been taken at this time), but i believe it is important that you, as the manufacturer of this product, which is widely prescribed and used by runners and others when experiencing knee pain, be aware that this incident occurred and consider whether the use of this band, which inhibits the movement of the kneecap, could have been a contributing factory in my injury.I think it is also important for you to investigate whether others have been affected by similar incidents and if so, perhaps consider whether these bands should carry warning labels and/or whether professionals who prescribe such bands should be warned of the potential negative consequences of the use of these bands.I should assure you i am not seeking financial compensation in any way, but i am also contacting the us food and drug adminstration since i understand that they are responsible for overseeing the safety of medical devices manufactured in the united states.I hope you will do your best to investigate this and am happy to provide you with additional information if necessary.I look forward to hearing from you.Best wishes, (b)(6).

• Brand Name: CHO-PAT ORIGINAL KNEE STRAP
• Type of Device: CHO-PAT ORIGINAL KNEE STRAP
• Manufacturer (Section D): MEDI-DYNE HEALTHCARE PRODUCTS
• MDR Report Key: 4402947
• MDR Text Key: 5305081
• Report Number: MW5040095
• Device Sequence Number: 1
• Product Code: IQI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 420MM LONG AND 50 MM WIDE BAND
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Weight: 64