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

Catalog Number MDS86850E

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 08/01/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that the rollator "broke," the end-user experienced an unidentified knee injury, and was admitted to a hospital.Despite multiple good-faith attempts the end-user was unable or unwilling to provide additional information to the manufacturer.Use of the rollator as well as the type of rollator break that occurred at the time of the incident are unknown.No information regarding diagnostic exams/results, medical intervention, or admitting diagnoses was reported to the manufacturer.No sample was returned to the manufacturer for evaluation.A root cause for the reported incident could not be determined.Due the reported hospitalization, 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 rollator "broke," the end-user experienced an unidentified knee injury, and was admitted to a hospital.

• 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: 9071784
• MDR Text Key: 170107466
• Report Number: 1417592-2019-00159
• 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: consumer
• Type of Report: Initial
• Report Date: 09/16/2019

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?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS86850E
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/20/2019
• Initial Date FDA Received: 09/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other