MAUDE Adverse Event Report: INVACARE TAYLOR STREET ROLLATOR 9153651315; WALKER, MECHANICAL

Model Number UNKNOWN

Device Problem Entrapment of Device (1212)

Patient Problems Fall (1848); Physical Entrapment (2327); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

The end user fell down at her bed and got her leg caught between the cable and the frame down towards the rear wheel.She has cut herself considerably and remained in the hospital for this.The jazz is the same /similar to all invacare rollators which are, or have been manufactured and/or marketed by invacare in u.S.The alleged incident occurred in (b)(6).

Event Description

The end user fell down at her bed and got her leg caught between the cable and the frame down towards the rear wheel.She has cut herself considerably and remained in the hospital for this.The jazz is the same /similar to all invacare rollators which are, or have been manufactured and/or marketed by invacare in u.S.The alleged incident occurred in (b)(6).

• Brand Name: ROLLATOR 9153651315
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer (Section G): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5525756
• MDR Text Key: 41132093
• Report Number: 1525712-2016-00873
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 03/23/2016

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/23/2016
• Initial Date FDA Received: 03/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1