MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. DEROYAL; ANKLE STIRRUP

Model Number 1-502A-98

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/01/2016

Event Type  malfunction  

Manufacturer Narrative

Supplemental information: the complaint text states that the complaint item was an ankle stirrup with an air bladder.However, the part number listed in the complaint entry, 1-502a-98, is a walking boot.When the complaint sample was received by the qc investigator, it was shown to be an ankle stirrup without an air bladder.The qc investigation report below was performed on the complaint sample returned, an ankle stirrup without an air bladder.Qc investigation: investigation findings: the complaint sample was returned.The product shows sign of wear/use.The returned sample is manufactured to current specifications the memory foam padding completely covers the shell and is not damaged/broken down.There were no manufacturing defects/errors found; root cause: investigator is unable to determine root cause as there were no manufacturing defect/issues found; corrections: credit was requested/issued; corrective action: there is no corrective action required at this time, the returned sample was not found to be defective; preventive action: there is no preventive action required at this time, the returned sample was not found to be defective.No further information is available at this time.We will provide follow up report if additional information becomes available.

Event Description

No injury was reported.Detailed description of quality issue: replaced patient's ankle stirrup brace because the padding was deflating and causing the plastic to rub skin.Detailed description of outcome(s), including information regarding injury or any additional treatment/intervention required: patient was given a new brace.

• Brand Name: DEROYAL
• Type of Device: ANKLE STIRRUP
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1703 hwy 33 south; new tazewell TN 37825
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1703 hwy 33 south; new tazewell TN 37825
• Manufacturer Contact: elizabeth reed ; 200 debusk ln; powell 37849 ; 8653621256
• MDR Report Key: 5999347
• MDR Text Key: 56448203
• Report Number: 1060680-2016-00026
• Device Sequence Number: 1
• Product Code: ITW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1-502A-98
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2016
• Date Manufacturer Received: 09/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other