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

Catalog Number MDS86850E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 12/06/2018

Event Type  Injury  

Manufacturer Narrative

It was reported that the end-user experienced a fall.Reportedly, the end-user was walking on a sidewalk and did not see that the sidewalk had a crack.As the end-user walked over it, the front wheels of the rollator became caught in the sidewalk crack.The end-user experienced a forward fall onto his right foot and onto the sidewalk.Reportedly, the end-user was taken to a local hospital's emergency department (ed) where an x-ray of his right foot was obtained.The x-ray indicated that he experienced a fracture to his right foot.The end-user was provided with a temporary cast and discharged home from the ed to follow-up with a specialist.No additional diagnostic tests were reported to the manufacturer.No medical intervention was reported to the manufacturer.No sample was returned to the manufacturer for evaluation.Due to the reported incident, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that the end-user experienced a fall and a fracture to his right foot.

• Type of Device: ROLLATOR,BASIC,BURGUNDY
• 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: 8202425
• MDR Text Key: 131595897
• Report Number: 1417592-2018-00143
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/28/2018

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: MDS86850E
• Device Lot Number: 88517110004
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/07/2018
• Initial Date FDA Received: 12/28/2018
• 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): Disability
• Patient Age: 53 YR
• Patient Weight: 41