MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; ROLLATOR,BASIC,BLUE

Catalog Number MDS86850EB

Device Problem Break (1069)

Patient Problem Tooth Fracture (2428)

Event Date 02/12/2019

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2019, the end-user reported that while he was walking in the kitchen using the rollator, the right rear leg broke resulting in end-user falling onto the tile and wooden floor.There was no medical intervention, serious injury or follow-up care reported related to this event at this time.On (b)(6) 2019, the end-user called and stated that when he fell, he hit his face onto the side of the wall and then he hit his head again onto the floor.Reportedly, the end user's posterior right upper tooth fractured.It was denied that end-user went to a healthcare provider or to a dentist to be evaluated related to this incident.Due to the reported fractured tooth, this medwatch is being filed.The sample is not available to be returned for evaluation.A definitive root cause could not be determined at this time.No additional information is available.If additional information becomes available, this report will be reopened and reevaluated.

Event Description

It was reported that the rollator's right rear leg broke resulting in end-user falling and his posterior right upper tooth breaking off.

• Type of Device: ROLLATOR,BASIC,BLUE
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: bermon punzalan ; three lakes drive; northfield, IL 60093
• MDR Report Key: 8407676
• MDR Text Key: 138567849
• Report Number: 1417592-2019-00031
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/11/2019

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: MDS86850EB
• Device Lot Number: 05417100003
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/12/2019
• Initial Date FDA Received: 03/11/2019
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Weight: 108