MAUDE Adverse Event Report: JAN MAO INDUSTRIES, CO, LTD. LUMEX; RAISED TOILET SEAT

Model Number 6487RA

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Fracture, Arm (2351)

Event Date 08/12/2015

Event Type  Injury  

Event Description

End-user's daughter alleges her mother was using her new raised toilet seat when she heard her mother scream.When she entered the bathroom she found the toilet seat completely off the toilet and tilted on it's side.Her mother was lying on the floor.The dealer stated they delivered and installed the raised toilet seat for their customer/end-user.Following the installation, they received a call stating the toilet seat was loose.The dealer went back to the residence to re-inspect the product.Finding no visual malfunction or defect the dealer re-installed the toilet seat and instructed the customer to use both hands when rising off the unit to ensure even distribution of weight.

• Brand Name: LUMEX
• Type of Device: RAISED TOILET SEAT
• Manufacturer (Section D): JAN MAO INDUSTRIES, CO, LTD.; no. 181 chu liao road; tasu district; kao hsiung city, kaohsiung ; TW
• MDR Report Key: 5051189
• MDR Text Key: 24874564
• Report Number: 2428983-2015-00004
• Device Sequence Number: 1
• Product Code: ILS
• 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
• Report Date: 09/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 6487RA
• Device Lot Number: JAQ300BS
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/01/2015
• Distributor Facility Aware Date: 08/19/2015
• Device Age: 1 MO
• Event Location: Home
• Date Report to Manufacturer: 08/28/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR
• Patient Weight: 73