MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; ROLLATOR,BASIC,STEEL,6",BURGUNDY

Catalog Number MDS86850ES

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Skin Tears (2516)

Event Date 08/03/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported that while the end-user was sitting in the rollator, the left front wheel of the device detached.The end-user experienced a "backwards and sideways" fall onto her kitchen's vinyl floor.She was assisted back up by a family member and a "full thickness skin tear" was noted to her left lower leg.The end-user has reportedly required home health care for the skin tear.No specific medical treatment was reported to the manufacturer.No sample was returned to the manufacturer for evaluation.A root cause for the reported incident was unable to be determined.Due to the reported need for follow-up care, 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 a rollator wheel detached and the end-user experienced a fall.

• Type of Device: ROLLATOR,BASIC,STEEL,6",BURGUNDY
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, il ; 9311458
• MDR Report Key: 10456934
• MDR Text Key: 206128761
• Report Number: 1417592-2020-00091
• 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: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/26/2020

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: MDS86850ES
• Device Lot Number: 88517110003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/06/2020
• Initial Date FDA Received: 08/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Weight: 47