MAUDE Adverse Event Report: PREMIER GUARD ZHONGSHAN LIMITED DEROYAL; WALKING BOOT (WALKER)

Model Number 15520006

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Fall (1848); Pain (1994)

Event Date 12/13/2016

Event Type  malfunction  

Manufacturer Narrative

The investigation into this complaint is in progress.No further information is available at this time.We will provide follow up report if additional information becomes available.

Event Description

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.Detailed description of quality issue: the bottom rubber came off of the boot.How was the quality issue was identified? by actual use.How was the product being used? customer states she was walking down stairs.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: required medical attention to prevent impairment.Details of medical attention required to prevent impairment: lower back and left side of body pain.Person(s) affected by outcome(s) checked above: patient.Known pre-existing condition(s) of person(s) affected: lt foot fracture.Was the incident reported to the fda? no.Detailed description of outcome(s), including information regarding injury or any additional treatment/intervention required: customer states that she was walking down stairs.The bottom rubber came off of the boot leaving bottom of boot slick.She grabbed the handrail but fell down 3 to 4 steps.This resulted in low back and left side that is swollen and sore.Was seen by physician, has no broken bones and will be receiving physical therapy.

Manufacturer Narrative

Investigation findings: the complaint sample was not returned.The end user provided a photo of a boot with the sole unattached, but did not have the original packaging with item and lot number information.Since the customer did not have the original packaging, she obtained the part number from label on replacement boot obtained from her doctor.Based on the picture sent by the customer, we are unable to confirm that this boot is an inline walker and sold by deroyal.In addition, there was no information given about the length of time the product was worn/used.In 2010, an issue was found and corrected by the vendor on the gluing of the rubber sole bottom.Since not product was returned and no lot number was provided for the complaint in question, if the product is an inline walker sold by deroyal, we are unable to determine if the product in question was made before the vendor corrective action was implemented.(b)(4).Product in house was inspected and no issues were found.The vendor was issued a supplier corrective action request (scar) for the complaint in question.If vendor investigation leads to any new findings, a follow up report will be filed.Root cause: due to the lack of sample or lot number, it is not possible to determine a root cause.It is possible that the reported issue is related to previous vendor issues, without a lot number being reported that cannot be confirmed.Known vendor issues were already corrected by the vendor.Corrective action: there is no corrective action required at this time, no root cause was found.Preventive action: there is no preventive action required at this time, no root cause was found.No further information is available at this time.We will provide follow up report if additional information becomes available.

Manufacturer Narrative

The complaint sample was returned on 03/10/2017.The product showed signs of wear/use and the sole had come unglued from the base of the boot.The lot number was found inside the boot by quality control, lot number 1101159.In 2010, an issue was found and corrected by the vendor regarding the gluing of the rubber sole bottom.This lot was manufactured by the vendor in jan, 2011.A supplier corrective action request (scar) was issued to the vendor and returned for the complaint in question.Product in house was inspected and no issues were found.According to the returned supplier corrective action request (scar) information, the vendor checked their manufacturing process and no violations of procedures and technical parameters of production were found.Between, january 1, 2015 - april 4, 2017 there have been (b)(4) units sold and no other complaints reported for the 15520006 product related to the sole coming off.No further information is available at this time.We will provide a follow up report if additional information becomes available.

Event Description

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.Detailed description of quality issue: the bottom rubber came off of the boot.How was the quality issue was identified? by actual use.How was the product being used? customer states she was walking down stairs.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: required medical attention to prevent impairment.Details of medical attention required to prevent impairment: lower back and left side of body pain.Person(s) affected by outcome(s) checked above: patient.Known pre-existing condition(s) of person(s) affected: lt foot fracture.Was the incident reported to the fda? no.Detailed description of outcome(s), including information regarding injury or any additional treatment/intervention required: customer states that she was walking down stairs.The bottom rubber came off of the boot leaving bottom of boot slick.She grabbed the handrail but fell down 3 to 4 steps.This resulted in low back and left side that is swollen and sore.Was seen by physician, has no broken bones and will be receiving physical therapy.

• Brand Name: DEROYAL
• Type of Device: WALKING BOOT (WALKER)
• Manufacturer (Section D): PREMIER GUARD ZHONGSHAN LIMITED; no 52, huan mao yi road; torch development zone; zhongshan guangdong, 52840 0; CH 528400
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1703 hwy 33 south; new tazewell TN 37825
• Manufacturer Contact: melissa logsdon ; 200 debusk ln; powell 37849 ; 8653626157
• MDR Report Key: 6254403
• MDR Text Key: 64922860
• Report Number: 1060680-2017-00002
• Device Sequence Number: 1
• Product Code: IQI
• 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,Followup,Followup
• Report Date: 12/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Model Number: 15520006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2017
• Date Manufacturer Received: 12/16/2016
• 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