MAUDE Adverse Event Report: ZHONGSHAN BLISS MEDICAL DRIVE DEVILBISS HEALTHCARE; WALKER, MECHANICAL

Model Number	KA2200-2GWP
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	07/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a walker by the end user's mother who stated that the end user fell forward receiving two stitches.The device was returned for evaluation.The device's rear wheel was loose and misaligned causing the wheel to operate at an angle and rub against the override bracket causing damage to the bracket.With the damage override bracket, the override rear brake can easily detach from the bracket and fall down when it engages the one directional feature.This can cause the walker to brake when going in one direction which can cause the end user to fall.Product labeling instructs the user to regularly inspect and tighten nuts and bolts.Drive devilbiss healthcare concludes the misaligned wheel caused interference, likely damaging the bracket.As part of its complaint review and evaluation process, drive devilbiss healthcare will also notify the manufacturer of the product about this complaint.

• Brand Name: DRIVE DEVILBISS HEALTHCARE
• Common Device Name: WALKER, MECHANICAL
• Manufacturer (Section D): ZHONGSHAN BLISS MEDICAL; no. 98 zhaoyi road; dongsheng town; zhongshan city, zhongshan 52841 4; CH 528414
• MDR Report Key: 20421215
• Report Number: 2438477-2024-00051
• Device Sequence Number: 15536281
• Product Code: ITJ
• UDI-Device Identifier: 00822383583853
• UDI-Public: 00822383583853
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/10/2024
• Report Date (Section F): 10/10/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: KA2200-2GWP
• Device Catalogue Number: KA2200-2GWP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2024
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/01/2024
• Event Location: Home
• Date Report to Manufacturer: 10/10/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/10/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 4 YR
• Patient Sex: Female
• Date Report Sent to FDA: 10/10/2024