MAUDE Adverse Event Report: DEROYAL INDUSTRIES INC. DEROYAL; KNEE SUPPORT, OPEN PATELLA, M

Model Number NE7702-73

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Skin Erosion (2075)

Event Date 04/07/2015

Event Type  malfunction  

Event Description

The end user reported the incident as follows: i am a (b)(6) surgery resident and i recently saw my orthopedic surgeon and was diagnosed with patellofemoral syndrome.I was given a deroyal neoprene knee brace at my visit.I ran with this brace and felt immediately better - for the first half of my run.I then developed ulcerations on the posterior aspect of my knee and had to take the brace off.Is this a common problem with this brace? do you have other products that are recommended for running? i am very disappointed with the result and wondered what your suggestions might be.

Manufacturer Narrative

Investigation findings: the complaint sample was not returned, several attempts were made to collect the sample using (b)(4).The lot was not listed.Product on hand at (b)(4) was reviewed at random, no product defect was found.Correction: none required.Root cause analysis: unable to determine, lack of sample.Corrective action and/or systemic correction action taken: no action is required at this time, no manufacturing issue was found during an in house review, the complaint sample was not returned.No action is required at this time, no manufacturing issue was found during an in house review.

• Brand Name: DEROYAL
• Type of Device: KNEE SUPPORT, OPEN PATELLA, M
• Manufacturer (Section D): DEROYAL INDUSTRIES INC.; powell TN
• Manufacturer Contact: 200 debusk lane; powell, TN 37849 ; 8653621013
• MDR Report Key: 4745038
• MDR Text Key: 19317254
• Report Number: 1123071-2015-00004
• Device Sequence Number: 1
• Product Code: ITQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NE7702-73
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/07/2015
• Event Location: Other
• Date Manufacturer Received: 04/07/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other