MAUDE Adverse Event Report: NINGBO SHENYU MEDICAL EQUIPMENT DRIVE; BATH BENCH

Model Number	12486
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Insufficient Information (4580)
Date of Event	02/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On february 8, 2022, (b)(4) healthcare was notified of an incident involving a bath bench.The end user's husband stated that the chair "had a catastrophic failure" and submitted one close-up photograph that seems to depict the underside of the bench at the point where one of the legs would connect with the seat, which appears to have been ripped out in some unknown manner.The reporter stated that the failure "crushed her leg in the process," and later confirmed that she sought medical attention and was treated for a sprain and bruises with ibuprofen.The chair was discarded and therefore cannot be returned for evaluation.

• Brand Name: DRIVE
• Common Device Name: BATH BENCH
• Manufacturer (Section D): NINGBO SHENYU MEDICAL EQUIPMENT; wt of tanjialing rd; yuyao, zhejiang 31540 8; CH 315408
• MDR Report Key: 14105644
• Report Number: 2438477-2022-00026
• Device Sequence Number: 12333279
• Product Code: ILS
• UDI-Device Identifier: 00822383108902
• UDI-Public: 822383108902
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 04/13/2022
• Report Date (Section F): 04/13/2022

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
• Operator of Device: Lay User/Patient
• Device Model Number: 12486
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/08/2022
• Device Age: 5 YR
• Event Location: Home
• Date Report to Manufacturer: 04/18/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/13/2022
• 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 Sex: Female
• Patient Weight: 108 KG
• Date Report Sent to FDA: 04/13/2022