MAUDE Adverse Event Report: NINGBO SHENYU DRIVE; BATH BENCH

Model Number	12486
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Fall (1848); Pain (1994)
Date of Event	02/13/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4) is the initial importer of the device which is a bath bench.The device was in use by the end-user for a year.Pms does not anticipate return of the device for evaluation.Patient requires compensation.The end-user was sitting on chair in his shower and the chair collapsed.The bracket connecting the seat to the legs had failed.His neck and back hit the wall.He injured his tailbone.Physical therapy and a chiropractor was required.He noted that the device was stored in a dry area of the bathroom.

• Brand Name: DRIVE
• Common Device Name: BATH BENCH
• Manufacturer (Section D): NINGBO SHENYU; west of tanjialing road; juyao; zhejiang,, 31540 8; CH 315408
• MDR Report Key: 8458364
• Report Number: 2438477-2019-00012
• Device Sequence Number: 344454
• Product Code: ILS
• UDI-Device Identifier: 00822383108902
• UDI-Public: 822383108902
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/11/2019
• Report Date (Section F): 03/27/2019

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 Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/11/2019
• Device Age: 13 MO
• Event Location: Home
• Date Report to Manufacturer: 03/29/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2019
• 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: Required Intervention
• Patient Age: 35 YR
• Patient Weight: 92
• Date Report Sent to FDA: 03/27/2019