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

Catalog Number WRX449724

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problems Fall (1848); Joint Dislocation (2374)

Event Date 04/14/2018

Event Type  Injury  

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 Description

It was reported that a rollator wheel broke off and the end-user experienced a fall and a right-sided shoulder dislocation.

• Type of Device: ROLLATOR,SUPER LIGHT,250LB CAP.
• 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: 7502022
• MDR Text Key: 107832754
• Report Number: 1417592-2018-00027
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00311917124711
• UDI-Public: 311917124711
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/19/2018
• Initial Date FDA Received: 05/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 99