MAUDE Adverse Event Report: JIANLIAN HOMECARE PRODUCTS DMI; BATH STOOL

Model Number 522-0797-1900

Device Problem Collapse (1099)

Patient Problems Laceration(s) (1946); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 01/10/2024

Event Type  Injury  

Event Description

Had to call paramedics.They took me to hospital emergency.I had cut my arm.Also hu ankles.I have lower back muscle spasms.The emergency doctor prescribed pain meds a this bench is rated for 300 lbs.I am 250 lbs.This happened 1/10/2024 i still have pain i would not recommend this bench to anyone.I called amazon to get their cont no info.So i hope some from dmi sees this and contacts me.

Manufacturer Narrative

Incident was reported through an amazon review and not to our organization.The customer gave no details about the event, and left no contact information for us to follow up.

• Brand Name: DMI
• Type of Device: BATH STOOL
• Manufacturer (Section D): JIANLIAN HOMECARE PRODUCTS; dali xiebian industrial park,n; foshan, guangdong 52823 1; CH 528231
• MDR Report Key: 18576429
• MDR Text Key: 333659097
• Report Number: 1000143485-2024-23400
• Device Sequence Number: 1
• Product Code: IKX
• UDI-Device Identifier: 00041298990765
• UDI-Public: 0041298990765
• 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
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 522-0797-1900
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/18/2024
• Event Location: Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Female
• Patient Weight: 113 KG