MAUDE Adverse Event Report: MEDI USA, L.P. DEROYAL; KNEE BRACE

Model Number 480-13

Device Problem Break (1069)

Patient Problem Skin Irritation (2076)

Event Date 01/26/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation findings: the product is not made by deroyal industries, inc.It is made by medi usa, l.P.This product is no longer sold by deroyal.The product was not returned to deroyal, therefore it could not be inspected or evaluated.Replacement parts were sent to the initial reporter, mr.(b)(6).The customer was satisfied that he would be able to repair brace with replacement parts.Corrections: replacement parts were sent to the initial reporter, mr.(b)(6).Customer satisfied that he would be able to repair brace with replacement parts.Corrective action: a supplier notification letter (snl) will be sent out to inform the supplier of this complaint.Preventive action: there are no preventive actions needed at this time.No further information is available at this time.We will provide follow up report if additional information becomes available.

Event Description

Copied below are responses given by the initial reporter to the deroyal complaint questionnaire.Quality issue details: date of occurrence: (b)(6) 2016.When did quality issue occur? during use.Who was using or operating the product when the quality issue occurred? patient/end consumer.Was a medical procedure involved? no.Name of medical procedure: not applicable.Did the quality issue cause a delay in the medical procedure? not applicable.Detailed description of quality issue: pt has rash from brace where the velcro has come apart.How was the quality issue was identified? by actual use.How was the product being used? as described.Was it the initial use of the product? yes.Was the product modified from the original condition supplied by deroyal? no.Was the product connected to or used in conjunction with other devices or outcome details: outcome(s) attributed to quality issue: none.Person(s) affected by outcome(s) checked above: patient.Known pre-existing condition(s) of person(s) affected: none specified.Was the incident reported to the fda? no.

• Brand Name: DEROYAL
• Type of Device: KNEE BRACE
• Manufacturer (Section D): MEDI USA, L.P.; 6481 franz warner pkwy; whitsett NC 27377
• Manufacturer (Section G): MEDI USA, L.P.; 6481 franz warner pkwy; whitsett NC 27377
• Manufacturer Contact: marian vargas ; 200 debusk ln; powell 37849 ; 8653621013
• MDR Report Key: 5460411
• MDR Text Key: 39467576
• Report Number: 1060680-2016-00001
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/26/2016,02/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 480-13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/26/2016
• Date Manufacturer Received: 01/26/2016
• 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