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

Catalog Number MDS86825SLR

Device Problems Break (1069); Mechanical Problem (1384)

Patient Problem Fracture, Arm (2351)

Event Date 11/22/2017

Event Type  Injury  

Manufacturer Narrative

It was reported that the customer was sitting on the rollator and rolling around the kitchen when the right front wheel sheared off resulting in the customer falling to the ground.The customer caught herself with her right arm which resulted in the customer breaking her arm.The customer went to the emergency department where she was diagnosed with a fracture of the right arm, had the right arm splinted, and was prescribed unknown pain medication.Due to the reported incident and subsequent need for medical intervention, this medwatch is being filed.The sample related to the incident is not available for evaluation.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the customer was sitting on the rollator and the front wheel broke resulting in the customer falling.

• Type of Device: ROLLATOR, SUPERLIGHT, BURGUNDY
• Manufacturer (Section D): MEDLINE INDUSTRIES INC; three lakes dr; northfield IL 60093
• Manufacturer (Section G): MEDLINE INDUSTRIES INC; three lakes dr.; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes dr.; northfield, IL 60093 ; 8476434960
• MDR Report Key: 7066435
• MDR Text Key: 93174076
• Report Number: 1417592-2017-00082
• 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: Patient
• Type of Report: Initial
• Report Date: 11/29/2017

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: 88516090024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/27/2017
• Initial Date FDA Received: 11/29/2017
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Weight: 109