MAUDE Adverse Event Report: JAN MAO INDUSTRIES CO. LTD. HEMI WALKER, ADULT; WALKER, MECHANICAL

Model Number CWAL1028H~TPMECC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fall (1848)

Event Date 11/17/2021

Event Type  Injury  

Manufacturer Narrative

The complaint was forwarded to the manufacturing facility where it is currently still under investigation.A follow-up report will be filed once the results have been completed.

Event Description

Consumer reported concern that rivets came loose as the walker popped and came apart.He allegedly injured himself while using the hammy walker on a hiking trail.Consumer reportedly tumbled down from the trail and fractured his finger and left leg and broke three teeth.

Manufacturer Narrative

Supplemental report is being filed since investigation has been completed and due to correction of the product number in section d4.The product number on the original report was cwal1028hr, but the customer reported the actual product number matching the lot number is cwal1028h.Based on supplier investigation, lot number 8400012019-sh was shipped in may 2020.The device history record(dhr) review did not indicate any exception that could lead to the reported incident.The event device was not returned for investigation.Additional review of the dhr, revealed no issues were detected during production and inspection.Review of the device master record revealed there was no change to design, production process, as well as the related materials.The four rivets portion of the walker have a tube inserted inside of each main tube to increase the strength of the four rivets portion.Based on the complaint description, the customer was concerned the rivets came loose as the walker popped and came apart.The supplier was not able to assess whether the user found any specific abnormal issue with the walker, or any special reason to cause the reported concern.According to the ifu which mentioned / warning, all four legs of the hemi walker must be adjusted to an equal height so that it sits level before using.Additionally, user should also watch out for potential safety hazards including slippery, uneven, or soft surfaces and objects in the walking path.Supplier was not able to determine if the customer's reported issue occurred because the hiking trail was uneven, improper use of the walker, or just an accident.The failure could not be confirmed, and the root cause could not be determined from this investigation.The complaint information was shared with the relevant sectors for their awareness.The supplier will continue to monitor the trends for this type of incident.

• Brand Name: HEMI WALKER, ADULT
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): JAN MAO INDUSTRIES CO. LTD.; gong ting village, first indus; long xi town bo luo hsing; hiu zhou city,gong dong provid 51612 1; CH 516121
• Manufacturer (Section G): JAN MAO INDUSTRIES CO. LTD.; gong ting village, first indus; long xi town bo luo hsing; hiu zhou city,gong dong provid 51612 1; CH 516121
• Manufacturer Contact: patricia tucker ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 13005555
• MDR Text Key: 287284142
• Report Number: 1423537-2021-00700
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/28/2022

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: Lay User/Patient
• Device Model Number: CWAL1028H~TPMECC
• Device Catalogue Number: CWAL1028H~TPMECC
• Device Lot Number: 8400012019-5H-2005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/18/2021
• Event Location: Other
• Initial Date Manufacturer Received: 11/18/2021
• Initial Date FDA Received: 12/14/2021
• Supplement Dates Manufacturer Received: 11/18/2021
• Supplement Dates FDA Received: 02/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Sex: Male