MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. DEROYAL; WRIST SPLINT

Model Number 5068-00

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Wheal(s) (2241)

Event Date 07/15/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation findings: this complaint was filed by a user of the 5068-00 wrist splint product via a written letter to our company.The customer did not provide a telephone number or return the complaint sample.Deroyal sent a letter to follow up on getting the sample back to the return address.However, there has been no response.Therefore there was no complaint sample to analyze.Product on hand at our distribution facility was reviewed at random.There were no manufacturing issues or defects found for these.There has only been one similar complaint for this device, it was filed in 2010.During a review of that complaint the investigator found that the customer reported a sharp edge on the product.During a review of the complaint sample, it was noted that the hook was poking through the binding on the brace and irritating the customer's skin under the brace.Deroyal immediately took action and changed the poly binding on the brace to cotton, preventing this issue in the future.No further complaint had been filed about abrasiveness or sharp edges, until this current complaint.The failure mode for complaint from 2010 is different than the current one.The current complaint involves outer edges of brace begin sharp potentially scratching areas that the brace touches.The conclusion from findings is that we are unable to verify sharp edges of product because it was not available for review.Root cause: unable to determine root cause, as the complaint sample was not returned.Corrections: replacement product was requested and sent.Corrective action: there is no corrective action required at this time, there were no issues found in house.Preventive action: there is no preventive action required at this time.No further information is available at this time.We will provide follow up report if additional information becomes available.Device not returned to manufacturer.

Event Description

Complaint call text information is pasted below.*** 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: customer sent in letter."the design appears to be needlessly cumbersome, and it, and the outer material are abrasive in use.It is poised to readily inflict scrapes, cuts and scratches to one's face, and to any other exposed skin areas" how was the quality issue was identified? by actual use.How was the product being used? as directed.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 equipment? no.*** outcome details *** outcome(s) attributed to quality issue: irritation, reaction, rash.Details of irritation, reaction, rash (severity, medical treatment, etc.): see description above.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.Detailed description of outcome(s), including information regarding injury or any additional treatment/intervention required: customer sent letter to deroyal.

• Brand Name: DEROYAL
• Type of Device: WRIST SPLINT
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 200 debusk lane; powell TN 37849
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; km7 autopista joaquin balaguer; pisano free zone, building 18; santiago, dominican republic ; DR
• Manufacturer Contact: marian vargas ; 200 debusk ln; powell 37849 ; 8653621013
• MDR Report Key: 5897161
• MDR Text Key: 53794362
• Report Number: 3006851902-2016-00010
• Device Sequence Number: 1
• Product Code: ILH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 07/15/2016,08/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Model Number: 5068-00
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/15/2016
• Date Report to Manufacturer: 07/15/2016
• Date Manufacturer Received: 07/15/2016
• 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