MAUDE Adverse Event Report: FOSHAN NANHAI R. POON MEDICAL PRODUCTS CO., LTD. DIRECT SUPPLY RAISED TOILET SEAT W/O ARMS & LID

Model Number DSRTS6

Device Problem Material Integrity Problem (2978)

Patient Problems Fall (1848); Injury (2348)

Event Type  Injury  

Event Description

A resident dislocated her shoulder because she fell off the toilet on this raised toilet seat.The injured part was treated at a hospital/clinic and released.No other people were present at the time the incident had occurred.The raised toilet seat doesn't clamp well onto the customer's one-piece toilets.As the user was reaching around to flush the toilet, the whole assembly popped out, and she fell to the floor, injuring herself.The toilet, the raised toilet seat was put on was elongated - it is different from the two-piece toilets with the commode and tank, it is one big molded piece, so the riser doesn't seem to clamp as tightly onto it.The lip of this riser is also more shallow than some other raised toilet seats, which makes it unstable.The resident now has an arm sling due to this injury.

• Brand Name: DIRECT SUPPLY RAISED TOILET SEAT W/O ARMS & LID
• Type of Device: RAISED TOILET SEAT
• Manufacturer (Section D): FOSHAN NANHAI R. POON MEDICAL PRODUCTS CO., LTD.; new city district; danzao, nanhai; foshan guangdong, 52821 6; CH 528216
• MDR Report Key: 5671001
• MDR Text Key: 45685856
• Report Number: 3005182235-2016-00005
• Device Sequence Number: 1
• Product Code: ILS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/20/2016

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
• Device Operator: Lay User/Patient
• Device Model Number: DSRTS6
• 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: 05/20/2016
• Distributor Facility Aware Date: 04/29/2016
• Device Age: 15 MO
• Event Location: Other
• Date Report to Manufacturer: 05/20/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/23/2016
• 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: 87 YR
• Patient Weight: 104