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

Catalog Number MDS86845BKVS

Device Problem Collapse (1099)

Patient Problem Fall (1848)

Event Date 11/22/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that the rollator "collapsed" when the end-user sat down on the device and leaned back.The end-user experienced a fall on to his back and his head.Paramedics were called to the scene and the end-user was taken to a local hospital's emergency department (ed) where a "fully body ct scan, blood tests, ekg" were performed.No results were reported to the manufacturer.After the end-user's ed evaluation, he was reportedly admitted to the hospital where he stayed for "2.5 days" prior to being discharged home.No admitting diagnosis, additional diagnostic tests, or medical interventions were reported to the manufacturer.A sample was not available to be returned to the manufacturer for evaluation.A root cause for the reported incident was unable to be determined.Due to the reported need for hospital admission, this medwatch is being filed.If additional information becomes available this report will be reopened and reevaluated.

Event Description

It was reported that the rollator "collapsed" when the end-user sat down on the device and leaned back.

• Type of Device: ROLLATOR, EMPOWER, BLACK, MB
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753 ; 2249311458
• MDR Report Key: 9473472
• MDR Text Key: 176949173
• Report Number: 1417592-2019-00228
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2019

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 Catalogue Number: MDS86845BKVS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 88 YR
• Patient Weight: 91