MAUDE Adverse Event Report: ZHONGSHAN BLISS MEDICAL DRIVE; BATH SAFETY

Model Number	12202KD-1
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Fall (1848)
Date of Event	09/05/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial al importer of the device which is a shower char.We are filing this report in an over-abundance of caution due to an mdr regression analysis.The unit was not returned for evaluation.While using the device in the shower the leg broke, the end-user fell and hit her head on the sink.She went to the doctor.No serious injuries were sustained however, she attended therapy and stopped due to a swollen knee.Since the device was not returned and pictures not provided a root cause could not be ascertained.Historical data of complaints of the same nature were reviewed and found very limited reporting and a four percent defect rate over two years.

• Brand Name: DRIVE
• Common Device Name: BATH SAFETY
• Manufacturer (Section D): ZHONGSHAN BLISS MEDICAL; 98, zhaoyi road; dongsheng town,; zhongshan city,, guangdong, 52841 4; CH 528414
• MDR Report Key: 10968812
• Report Number: 2438477-2018-00090
• Device Sequence Number: 11397765
• Product Code: ILS
• UDI-Device Identifier: 50822383222061
• UDI-Public: 50822383222061
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/08/2020
• Report Date (Section F): 12/08/2020

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: 12202KD-1
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/05/2018
• Device Age: 8 MO
• Event Location: Home
• Date Report to Manufacturer: 12/10/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/08/2020
• 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 Weight: 91
• Date Report Sent to FDA: 12/08/2020