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

Model Number BRTL12606-AST

Device Problem Material Integrity Problem (2978)

Patient Problem Fall (1848)

Event Date 10/04/2022

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of an incident involving a bath stool by an end user's sister, who stated that the "shower chair collapsed under my brother while in shower and resulted in bruising across chest, ribs and coccyx area." the end user reportedly took tylenol for pain but did not seek further medical treatment.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.

Event Description

Drive devilbiss healthcare was notified of an incident involving a bath stool by an end user's sister, who stated that the "shower chair collapsed under my brother while in shower and resulted in bruising across chest, ribs and coccyx area." the end user reportedly took tylenol for pain but did not seek further medical treatment.Drive obtained the product for evaluation.The broken leg piece was confirmed, with a fracture point on the seat component.It could not be confirmed whether the fracture was present prior to the collapse or occurred as a result of a significant force exerted on the unit during an accident.

• Brand Name: DRIVE
• Type of Device: SHOWER CHAIR
• Manufacturer (Section D): NINGBO SHENYU MEDICAL EQUIPMENT CO., LTD.; west of tanjialing road; yuyao, zhejiang 31540 8; CH 315408
• MDR Report Key: 15699888
• MDR Text Key: 302705054
• Report Number: 2438477-2022-00111
• Device Sequence Number: 1
• Product Code: ILS
• UDI-Device Identifier: 00822383927305
• UDI-Public: 00822383927305
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: BRTL12606-AST
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/06/2023
• Distributor Facility Aware Date: 10/11/2022
• Device Age: 5 YR
• Event Location: Nursing Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 73 KG