MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. DEROYAL; WALKING BOOT

Model Number 15500043

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Bruise/Contusion (1754)

Event Date 06/22/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation findings: the customer was contacted to obtain further information.The customer had a walker boot with the inside liner ripping due to hook/loop strap, she did not know the part number of this original walker boot.She originally called in to order a new liner for her walker boot.However, those liners are not sold individually.Instead she was sent a new boot.This new boot is the subject of this complaint.The customer stated the following: the toe guard of the complaint sample was too close to her toes and that it touched the toes and caused discomfort.She also stated that the toe guard on both original and new boot were set to the longest setting.The foot part of the complaint sample was narrower than the original boot she was given.This was also uncomfortable.The original boot was flat on the floor when she stood up.The complaint sample was not flat and it caused her to shift to the side the original boot was a size medium.The lot number of the original sample was 5214.The complaint sample was received.It was confirmed the complaint sample was also a size medium.Quality control was unable to find any error/defect with the returned sample.This product is purchased from an outside vendor and is not made by deroyal.Throughout the history of the product, the vendor has made several changes to improve the design.Based on a review of the inventory, the lot of the complaint sample was1216.The lot number of the (original) boot that was preferred by the customer was 5214.It appears that the original boot received by the customer was a newer version than the replacement boot.The new versions have longer toe straps and lifted d-rings, which helps to "open up" the foot bed.This is why the customer felt more comfortable with her original boot and found the replacement boot uncomfortable.The customer prefers the newer version, and felt that it was more comfortable/roomy.The "adverse patient event" complaint to sales ratio for this product is (b)(4).Root cause: the original boot received by the customer was a newer version than the replacement boot.The new versions have longer toe straps and lifted d-rings, which helps to "open up" the foot bed.This is why the customer felt more comfortable with her original boot and found the replacement boot uncomfortable.The customer prefers the newer version, and felt that it was more comfortable/roomy.Corrections: the customer was able to keep the foam liner of the replacement boot and got the original boot frame back.She stated that she was satisfied.Corrective action: there is no corrective action required at this time, no vendor defect found, the differences in the two boots was related to product changes/improvements.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.

Event Description

The quality issue details and the outcome details section 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: this was a quality replacement for a liner that was destroyed by the velcro straps of previous boot.This replacement which is the same size is too narrow and too short.Customer states boot is rubbing her foot where the brackets are attached inside the boot and causing bruising.How was the quality issue was identified? by actual use.How was the product being used? as usual.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.): bruising.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 reported to deroyal.

• Brand Name: DEROYAL
• Type of Device: WALKING BOOT
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 200 debusk lane; powell TN 37849
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1703 hwy 33 south; new tazewell TN 37825
• Manufacturer Contact: marian vargas ; 200 debusk ln; powell 37849 ; 8653621013
• MDR Report Key: 5813706
• MDR Text Key: 50239310
• Report Number: 1060680-2016-00018
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/22/2016,07/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 15500043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2016
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/28/2016
• Event Location: Home
• Date Report to Manufacturer: 06/22/2016
• Initial Date Manufacturer Received: 06/22/2016
• Initial Date FDA Received: 07/21/2016
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other