MAUDE Adverse Event Report: COM-DA HEALTHCARE CO.,LTD DRIVE DEVILBISS HEALTHCARE; HYGIENE ADAPTER

Model Number	770-525
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Limb Pain (4836)
Date of Event	08/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a bath seat by the end user's son who stated the device's seat broke causing the end user to fall.The end user legs are weak and painful.The end user is having difficulty walking.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: HYGIENE ADAPTER
• Manufacturer (Section D): COM-DA HEALTHCARE CO.,LTD; no. 1, jinzhao street, west; district, no. 6 workshop ii; zhongshan city, guangdong 52840 0; CH 528400
• Manufacturer (Section G): COM-DA HEALTHCARE CO.,LTD; no. 1, jinzhao street, west; district, no. 6 workshop ii; zhongshan city, guangdong 52840 0; CH 528400
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7202545756
• MDR Report Key: 20059741
• Report Number: 3014644996-2024-00012
• Device Sequence Number: 15399879
• Product Code: ILS
• UDI-Device Identifier: 00754021210336
• UDI-Public: 00754021210336
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/25/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 770-525
• Device Catalogue Number: 770-525
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 08/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR
• Patient Sex: Female