MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; ROLLATOR

Catalog Number UNKNOWN

Device Problem Break (1069)

Patient Problem Fracture, Arm (2351)

Event Date 02/15/2018

Event Type  malfunction  

Manufacturer Narrative

It was reported that the customer was using the rollator for unspecified right knee problems and the front right leg of the rollator broke resulting in the customer falling and fracturing her left proximal humerus.It was not reported what part of the rollator leg broke or what occurred after the patient fell.The customer did go the emergency department for x-rays and it was noted that there was a fracture of the left humerus at the time of evaluation; however no additional fractures were noted.The customer was given a sling for her left upper arm immobilization and a prescription for percocet for the pain with no additional medical intervention documented.No sample has been returned for evaluation due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

It was reported that the customer was using the rollator for unspecified right knee problems and the front right leg of the rollator broke resulting in the customer falling and fracturing her left proximal humerus.

• Type of Device: ROLLATOR
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093 ; 8476434960
• MDR Report Key: 9349462
• MDR Text Key: 189881682
• Report Number: 1417592-2019-00201
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/20/2019

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/19/2019
• Initial Date FDA Received: 11/20/2019
• 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: 73 YR
• Patient Weight: 126