MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; ROLLATOR,SUPER LIGHT,250LB CAP.

Catalog Number	WRX449724
Health Effect - Clinical Codes	Fall (1848); Joint Dislocation (2374)
Date of Event	04/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that a rollator wheel broke off and the end-user experienced a fall and a right-sided shoulder dislocation.The end-user states she was sitting on the rollator and the right front wheel broke off of the frame and she experienced fall on to her kitchen floor.She went to a local hospital emergency department (ed) where a right shoulder x-ray was performed.The x-ray noted her right shoulder was dislocated but there were no acute fractures reported.No additional diagnostics reported.The end-user's right shoulder was reduced in the ed and she was discharged home.No additional treatments reported.A sample was returned to the manufacturer for evaluation and the reported product issue was confirmed.Due to the reported incident, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that a rollator wheel broke off and the end-user experienced a fall and a right-sided shoulder dislocation.

• Common Device Name: ROLLATOR,SUPER LIGHT,250LB CAP.
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 7502022
• Report Number: 1417592-2018-00027
• Device Sequence Number: 1698483
• Product Code: ITJ
• UDI-Device Identifier: 00311917124711
• UDI-Public: 311917124711
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 05/10/2018

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: WRX449724
• Device Lot Number: 88516090013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 05/10/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Weight: 99