MAUDE Adverse Event Report: UNKNOWN DRIVE; BATH BENCH

Model Number	12025KD
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Codes	Fall (1848); Head Injury (1879)
Date of Event	11/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) healthcare is the initial importer of the device which is a bath bench.The device has not been returned for evaluation.We are filing this report in an overabundance of caution.We will submit a follow-up when additional information becomes available.While in use the back leg folded.The end user fell and hit his head.He went to the emergency room for treatment.No additional data is available at this time.

• Brand Name: DRIVE
• Common Device Name: BATH BENCH
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 12881844
• Report Number: 2438477-2021-00074
• Device Sequence Number: 17134161
• Product Code: ILS
• UDI-Device Identifier: 00822383227573
• UDI-Public: 822383227573
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 11/29/2021
• Report Date (Section F): 11/29/2021

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: 12025KD
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/08/2021
• Device Age: 44 MO
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/29/2021
• 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: Hospitalization
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 191 KG
• Date Report Sent to FDA: 11/29/2021