MAUDE Adverse Event Report: NINGBO SHENYU MEDICAL EQUIPMENT CO., LTD. DRIVE; SHOWER STOOL

Model Number	12486
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Fall (1848)
Date of Event	09/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a shower stool by an end user, who stated that she was "sitting on it and it suddenly collapsed with [her] on it, causing a fall and some bruises." the end user reported that upon inspection, "two of the bolts used to hold the stationary leg of the stool are not there at all." the end user did not seek any medical treatment as a result of the incident.Multiple attempts to gather further information have been made, and to retrieve the product for evaluation, but drive has not received a response.Drive will continue to monitor complaints for any related trends.

• Brand Name: DRIVE
• Common Device Name: SHOWER STOOL
• Manufacturer (Section D): NINGBO SHENYU MEDICAL EQUIPMENT CO., LTD.; west of tanjialing road; yuyao, zhejiang 31540 8; CH 315408
• MDR Report Key: 16788509
• Report Number: 2438477-2022-00144
• Device Sequence Number: 5522500
• Product Code: ILS
• UDI-Device Identifier: 00822383108902
• UDI-Public: 00822383108902
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/21/2023
• Report Date (Section F): 04/21/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 12486
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/04/2022
• Event Location: Home
• Date Report to Manufacturer: 04/28/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/21/2023
• 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 Age: 18 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Date Report Sent to FDA: 04/21/2023