MAUDE Adverse Event Report: AID-PRO HEALTHCARE CO., LTD. VAUNN; RAISED TOILET SEAT

Model Number M705N-RAWH-APVM

Device Problem Unstable (1667)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 10/03/2018

Event Type  Injury  

Event Description

The customer called in to say her mom fractured two of her ribs after she fell from the raised toilet seat.She is reported as having complained of left side abdominal pain, and as having had x-rays on her ribs.

• Brand Name: VAUNN
• Type of Device: RAISED TOILET SEAT
• Manufacturer (Section D): AID-PRO HEALTHCARE CO., LTD.; no. 58 yu long 3 road; dong sheng town; zhong shan city, ; CH
• MDR Report Key: 8151944
• MDR Text Key: 129947706
• Report Number: 3012316249-2018-00058
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M705N-RAWH-APVM
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/11/2018
• Distributor Facility Aware Date: 11/19/2018
• Event Location: Home
• Date Report to Manufacturer: 12/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 85 YR
• Patient Weight: 49