MAUDE Adverse Event Report: DEROYAL INDUSTRIES TRANSITION POST-OP KNEE BRACE

Catalog Number KB7000-01

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Infection, Indirect (2245)

Event Type  malfunction  

Manufacturer Narrative

Investigation is incomplete at this time.A follow-up report will be submitted when more info becomes available.

Event Description

Post surgery - pt got infection because product rubbed the site - went to ed and pcp.Surgery was 4 months ago, was not made aware of the issue until contacted by (b)(6) on (b)(6), via email.Customer complaint attached to email.

• Brand Name: TRANSITION POST-OP KNEE BRACE
• Manufacturer (Section D): DEROYAL INDUSTRIES; 200 debusk lane; powell TN 37489
• Manufacturer Contact: 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 4617306
• MDR Text Key: 22224702
• Report Number: 1123071-2015-00002
• Device Sequence Number: 1
• Product Code: IQI
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: KB7000-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/11/2015
• Event Location: Home
• Date Report to Manufacturer: 02/11/2015
• Date Manufacturer Received: 02/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1