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

Model Number UNKNOWN

Device Problem Device Tipped Over (2589)

Patient Problem Fall (1848)

Event Date 08/23/2016

Event Type  malfunction  

Manufacturer Narrative

"we at the rehab clinic in (b)(4) received last week care a lady with a walker where the handle arm released and turned out when she was out walking.She fell on the walker and down a slope, but coped relatively well.We have made a medcontrol notification and sent both information and walker (b)(4).The walker was not excessively worn in general, and the woman had not noticed any instability in the handle before the accident.She is used to walk with a walker.The patient went outside with her walker futura 600 when one handle let go of the walker and was turned inward.The patient then fell over the walker and rolled down a slope.Coming the day after to the rehab clinic, feeling sore in the body and has a sore lower back, but is otherwise unharmed.Exchange walker and the broken walker returned to (b)(4) about medical technical error fall that led to low back pain and soreness in the body" the futura is the same /similar to all invacare rollators which are, or have been manufactured and/or marketed by invacare in u.S.This alleged incident occurred in the (b)(6).

Event Description

"we at the rehab clinic in (b)(6) received last week care a lady with a walker where the handle arm released and turned out when she was out walking.She fell on the walker and down a slope, but coped relatively well.We have made a medcontrol notification and sent both information and walker (b)(4).The walker was not excessively worn in general, and the woman had not noticed any instability in the handle before the accident.She is used to walk with a walker.The patient went outside with her walker futura 600 when one handle let go of the walker and was turned inward.The patient then fell over the walker and rolled down a slope.Coming the day after to the rehab clinic, feeling sore in the body and has a sore lower back, but is otherwise unharmed.Ecchange walker and the broken walker returned to (b)(4) about medical technical error fall that led to low back pain and soreness in the body" the futura is the same /similar to all invacare rollators which are, or have been manufactured and/or marketed by invacare in u.S.This alleged incident occurred in the (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: 5965941
• MDR Text Key: 55223440
• Report Number: 1525712-2016-02713
• Device Sequence Number: 1
• Product Code: IOR
• 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: 08/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 08/29/2016
• Initial Date FDA Received: 09/21/2016
• 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