MAUDE Adverse Event Report: MAXHEALTH CORP. DRIVE; BATH BENCH

Model Number	12202KD-1
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Concussion (2192)
Date of Event	10/09/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare received a letter from an attorney stating that the attorney's client sustained "serious injury" while using a shower chair that "collapsed under him." drive is attempting to evaluate the unit through the attorney and will provide an update when additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: BATH BENCH
• Manufacturer (Section D): MAXHEALTH CORP.; 14f, no. 99, section 1; xintai 5th road; new taipei, xizhi district 22102 ; TW 22102
• MDR Report Key: 15051209
• Report Number: 2438477-2022-00061
• Device Sequence Number: 4784506
• Product Code: ILS
• UDI-Device Identifier: 00822383148250
• UDI-Public: 00822383148250
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 07/19/2022
• Report Date (Section F): 07/18/2022

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 Model Number: 12202KD-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/10/2022
• Date Report to Manufacturer: 07/20/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/19/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 07/18/2022