MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; ROLLATOR

Catalog Number MDS86850EB

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problems Bruise/Contusion (1754); Fall (1848)

Event Date 08/01/2017

Event Type  Injury  

Manufacturer Narrative

It was initially reported last (b)(6) 2017 that on (b)(6) 2017, while end-user was walking in the parking lot using the rollator, the left back leg of the rollator snapped resulting in the end-user falling.Upon follow-up with the end-user on (b)(6) 2017, the end-user stated that she visited a physician the day after the incident for swelling to her left lower extremity and an x-ray was done with no report of fracture.No medical intervention, serious injury or follow up care was reported.Medline industries, inc.Received additional information last (b)(6) 2018 related to this event.Of note, prior to (b)(6) 2018, medline industries, inc.Has not received additional information related to this event.It was reported that the end-user, who takes coumadin and has history of chronic ulcers to bilateral lower extremities, developed hematoma to right lower extremity after experiencing the fall.The end-user reportedly required antibiotic treatment and visited the wound care clinic multiple times for compression wrapping, dressing changes and wound checks.Reportedly, an ultrasound of the right lower extremity was done with no evidence of deep vein thrombosis.Due to the reported need for continued follow-up and wound care, this medwatch is being filed.The sample was not available to be returned for evaluation.A photo was submitted and the reported broken left back leg of the rollator was confirmed.A definitive root cause could not be determined without the actual sample.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that the frame of the rollator broke and the wheel fell off resulting in the end-user experiencing two bruises on the left leg from a fall.

• 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: 7834114
• MDR Text Key: 118869333
• Report Number: 1417592-2018-00099
• 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: company representative,consum
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2018
• 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: N131139253
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 99