MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; ROLLATOR, STEEL, KNOCK-DOWN

Catalog Number MDS86850ESKD

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

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

Event Date 11/05/2018

Event Type  Injury  

Manufacturer Narrative

It was reported to the manufacturer that the front right wheel of the rollator had previously fallen off on multiple occasions.Reportedly, the end-user's physician and her husband re-attached and tightened the front right wheel following each occurrence.It was reported that the end-user experienced a fall and "broke" an unidentified shoulder after the reported wheel re-attachments and tightening.It is unknown how the end-user was using the rollator at the time of the reported fall.The manufacturer was not made aware of the reported product issue until the end-user experienced the fall.After multiple good-faith attempts, the end-user was unable or unwilling to provide additional information related to the product, the fall incident, and any diagnostic exams and/or medical treatments following the fall incident.No sample was returned to the manufacturer for evaluation.A root cause could not be determined.Due to the reported incident 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 "broke" an unidentified shoulder.

• Type of Device: ROLLATOR, STEEL, KNOCK-DOWN
• 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: 8115295
• MDR Text Key: 128749357
• Report Number: 1417592-2018-00134
• 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: 11/29/2018

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?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS86850ESKD
• Device Lot Number: 88515110029
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/05/2018
• Initial Date FDA Received: 11/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Weight: 120