MAUDE Adverse Event Report: ESSENTIAL MEDICAL SUPPLY ENDURANCE; SEAT CARE

Model Number W1450

Device Problems Break (1069); Collapse (1099)

Patient Problems Fall (1848); Injury (2348)

Event Date 05/25/2015

Event Type  Injury  

Event Description

Endurance w1450 broke at small plastic connection at back of seat, causing collapse of seat and occupant falling backward striking sharp culvert resulting in back injury.

• Brand Name: ENDURANCE
• Type of Device: SEAT CARE
• Manufacturer (Section D): ESSENTIAL MEDICAL SUPPLY
• MDR Report Key: 4825119
• MDR Text Key: 5906574
• Report Number: MW5042964
• Device Sequence Number: 1
• Product Code: IPS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 05/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: W1450
• Other Device ID Number: ESHH200902760
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR