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); Unspecified Tissue Injury (4559)

Event Date 04/30/2021

Event Type  Injury  

Manufacturer Narrative

It was reported to the manufacturer that, while using the rollator, the end-user experienced an unspecified injury that required an unspecified number of sutures.Despite multiple good faith attempts, the end-user was unable or unwilling to provide additional information about the incident to the manufacturer.No device failure or malfunction was originally reported and it is unknown how the device was being used at the time of the incident.No sample has been returned to the manufacturer for evaluation.A root cause has been unable to be determined.Due to the reported incident, and an 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 an unspecified injury during use of the rollator.

Manufacturer Narrative

Additional information was received from the end-user on 20-jun-2021.The end-user was walking to the bathroom when she experienced a backward fall.Reportedly, the end-user has noticed that the device "wobbles" and she has also had issues with the device brakes.Following the fall incident, the end-user was taken to a local hospital ed, via ems, where she received two (2) staples for a cut that she had experienced during the fall to the back of her head on the right side.The end-user reported that the staples were removed after ten (10) days and no further medical intervention or follow-up care was reported.The end-user has reportedly experienced headaches since the incident and has been taking an unidentified medication for pain control.The end-user discarded the device involved in the incident and no sample is available to be returned to the manufacturer for evaluation.A root cause for the reported incident was unable to be determined.If additional relevant information becomes available another supplemental medwatch will be filed.

• Type of Device: ROLLATOR,BASIC,BURGUNDY
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 11952543
• MDR Text Key: 254808939
• Report Number: 1417592-2021-00097
• 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,Followup
• Report Date: 06/21/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/17/2021
• Initial Date FDA Received: 06/07/2021
• Supplement Dates Manufacturer Received: 06/20/2021
• Supplement Dates FDA Received: 06/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 43