MAUDE Adverse Event Report: ZHONGSHAN LEBO MEDICAL DMI; SHOWER TRANSPORT CHAIR

Model Number	522-1702-1900
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Fall (1848)
Date of Event	06/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
We just bought this product off of amazon for my brother who is currently a paraplegic.He's only been using it since 6/5 and yesterday when he was in the shower the clip broke off of it and he fell in the shower.The strucral soundness of this product is very concerning to me.My brother is only 140lbs and does not reach the weight limit.Please let me know as soon as you can what we can do to resolve this issue.

• Brand Name: DMI
• Common Device Name: SHOWER TRANSPORT CHAIR
• Manufacturer (Section D): ZHONGSHAN LEBO MEDICAL; no. 60, weimin road; dongsheng town; zhonsheng town, guangdong 52841 4; CH 528414
• MDR Report Key: 17637593
• Report Number: 1000143485-2023-22523
• Device Sequence Number: 17727224
• Product Code: ILS
• UDI-Device Identifier: 00041298017028
• UDI-Public: 00041298017028
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 522-1702-1900
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/13/2023
• Device Age: 1 WK
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/28/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 64 KG