MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; ROLLATOR, SUPERLIGHT, BURGUNDY

Catalog Number MDS86825SLR

Device Problems Break (1069); Material Twisted/Bent (2981)

Patient Problem Hip Fracture (2349)

Event Date 09/30/2020

Event Type  Injury  

Manufacturer Narrative

The customer reported that the breaks gave way when seated and the device folded in half.The customer stated that she broke her hip and was planning on going to the hospital.No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.The sample has not been returned to the manufacturer for evaluation.Due to the reported incident 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

The customer reported that the device folded in half while she was seated and she broke her hip.

• Type of Device: ROLLATOR, SUPERLIGHT, BURGUNDY
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 10750566
• MDR Text Key: 213615934
• Report Number: 1417592-2020-00132
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/28/2020

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: MDS86825SLR
• Device Lot Number: 88518070003
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/02/2020
• Initial Date FDA Received: 10/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Weight: 103