MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. DEROYAL; KNEE BRACE

Model Number KB9000-01

Device Problems Deformation Due to Compressive Stress (2889); Material Deformation (2976)

Patient Problem Discomfort (2330)

Event Date 10/18/2016

Event Type  malfunction  

Manufacturer Narrative

The device for this quality issue has not been received for evaluation from the consumer.The device is expected to be returned.Upon receipt of the returned product, it will be tested and evaluated.There was no report of injury from the patient; irritation, reaction, rash were not experienced by the patient.We are unable to determine a root cause at this time, due to no sample.No further information is available at this time.We will provide a follow-up report if additional information becomes available.

Event Description

It was reported that the straps were bunching up and causing discomfort.A medical procedure was not involved.The quality issue was identified during actual use on the knee of the end user.It was the initial use of the product and the product was not modified from the original condition supplied by (b)(4).The product was not connected to or used in conjunction with other devices or equipment.A replacement was given to the end user.

• Brand Name: DEROYAL
• Type of Device: KNEE BRACE
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 164 giles hollow road; rose hill VA 24281
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 164 giles hollow road; rose hill VA 24281
• Manufacturer Contact: elizabeth reed ; 200 debusk lane; powell, TN 37849
• MDR Report Key: 6109922
• MDR Text Key: 60647860
• Report Number: 1123071-2016-00002
• Device Sequence Number: 1
• Product Code: ITQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: KB9000-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other