MAUDE Adverse Event Report: TRANSPORTER/ROLLATOR; WHEELCHAIR

Device Problems Misassembled (1398); Defective Device (2588)

Patient Problems Fall (1848); Pain (1994)

Event Date 06/15/2016

Event Type  Injury  

Event Description

Rollator transporter chair supplied by medline corp delivered thru care team in (b)(6) was defective.The back support was not properly assembled and when the patient sat down and back the support gave way and she tumbled out of chair.She aggravated her spine injury and had to resume treatment at her neurologist for back and rib pain.Medlife claim investigator issued new pins, but they too were useless as they did not hold the back rest in place.Presently my wife feels unsure using this chair as it is of no value to us.This is the second replacement.We are very unhappy with care team and medlife with this product.It is extremely dangerous to use.Thank you.(b)(6).

• Brand Name: TRANSPORTER/ROLLATOR
• Type of Device: WHEELCHAIR
• MDR Report Key: 5778345
• MDR Text Key: 49239381
• Report Number: MW5063296
• Device Sequence Number: 1
• Product Code: IOR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 07/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 102