MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC.; ROLLATOR

Catalog Number WRX449724

Device Problem Component Falling (1105)

Patient Problems Contusion (1787); Concussion (2192)

Event Date 06/04/2016

Event Type  Injury  

Manufacturer Narrative

The husband reported that when the end user sat down on the seat of the rollator, the wheel came off and she fell backwards.She hit her head and also suffered contusions to her left knee and hip.She had a loss of consciousness.She was evaluated in the emergency room and was diagnosed with a concussion.X-rays were performed and no fractures were identified.She had a follow up visit with her physician and was reported to be feeling much better.An incomplete sample was returned for evaluation.The returned sample was missing one of the wheels and the pin that holds this wheel in place.It is not known when or how the pin became missing.The threads of the returned wheel were inspected and found to be in good condition.The bolt that inserts the wheel into the leg was not stripped in any way.The returned wheel was intact and displayed no indications that it was loose or wobbly.The rear right side of the frame was scraped.The condition of the other wheel and its insertion bolt is not known.No manufacturing defect was identified during the sample return.A root cause has not been confirmed.However, due to the reported injury this medwatch is being filed.

Event Description

The wheel came off and the end user fell, suffering a concussion.

• Type of Device: ROLLATOR
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• Manufacturer Contact: julie finley ; one medline place; mundelein, IL 60060 ; 8476434709
• MDR Report Key: 5914843
• MDR Text Key: 53501386
• Report Number: 1417592-2016-00094
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: WRX449724
• Device Lot Number: M140371450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/16/2016
• Initial Date FDA Received: 08/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• 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
• Patient Outcome(s): Other
• Patient Age: 86 YR
• Patient Weight: 82