MAUDE Adverse Event Report: COMBO (ZHONG SHAN) MEDICAL EQUIPMENT CO.,LTD. DRIVE; BATH SAFETY BENCH

Model Number RTL12004KD

Device Problem Material Integrity Problem (2978)

Patient Problems Fall (1848); Head Injury (1879)

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of an incident involving a bath stool by an end user, who stated that she "leaned back to reach for something that was behind me and the leg gave way, completely bent.I fell back landing on my coccyx first, then the rest of my back and then my head hit the cabinet." the end user reported icing the affected area, taking ibuprofen for pain and seeing a chiropractor.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, who stated that she "leaned back to reach for something that was behind me and the leg gave way, completely bent.I fell back landing on my coccyx first, then the rest of my back and then my head hit the cabinet." the end user reported icing the affected area, taking ibuprofen for pain and seeing a chiropractor.The product was returned and evaluated.The root cause could not be determined as the end user weight was never provided to confirm if they were within weight capacity (300lbs) utilizing the shower stool.The defect rate for this specific issue is only (b)(4) in 2022 and only one complaint related for 2021.

• Brand Name: DRIVE
• Type of Device: BATH SAFETY BENCH
• Manufacturer (Section D): COMBO (ZHONG SHAN) MEDICAL EQUIPMENT CO.,LTD.; no.6 tongxing east road; dongsheng town; zhongshan city, guangdong 52841 4; CH 528414
• MDR Report Key: 15698944
• MDR Text Key: 302690098
• Report Number: 2438477-2022-00102
• Device Sequence Number: 1
• Product Code: ILS
• UDI-Device Identifier: 00822383246581
• UDI-Public: 822383246581
• 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: 11/30/2022

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: RTL12004KD
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/30/2022
• Distributor Facility Aware Date: 10/03/2022
• Device Age: 4 MO
• Event Location: Home
• Date Report to Manufacturer: 12/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Female