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

Catalog Number MDS86800XWS

Device Problem Collapse (1099)

Patient Problem Bruise/Contusion (1754)

Event Date 06/17/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported, the right wheel collapsed and end-user fell backwards on pavement striking his right shoulder and the back of his head.End-user transported to the emergency room (er).Phone call placed to end-user, who provided additional information in regards to this incident.Reporter confirms incident occurred (b)(6) 2021 in the parking lot of vacation bible school.Reporter states, he was sitting on the rollator, stationary watching the children playing when suddenly he fell backwards off the rollator striking his right shoulder and back of his head on the pavement.End-user reports, "the right back wheel collapsed, and is bent and stuck within the shaft of the rollator leg." reporter states, "one of the counselor's present that day is a nurse and she witnessed the entire incident." reporter states, an ambulance was called because he had hit his head and is taking a blood thinner.End-user states, at the time of incident he had no report of head pain, only right should pain.End-user reports, at the emergency room x-rays and a head cat scan were completed.Both exam results were negative and end -user was discharged home that day.End-user reports he continues to have "some neck and right shoulder discomfort" but states, he has no plans at this time to see or follow-up with his primary care physician.The sample is available for return and evaluation.End user would like a replacement rollator.Due to the reported incident, medical intervention and in an abundance of caution, this med watch is being filed.If any further relevant information is identified or obtained, a supplemental med watch will be submitted.

Event Description

It was reported, the right wheel collapsed and end-user fell backwards on pavement striking his right shoulder and the back of his head.End-user transported to the emergency room (er).

Manufacturer Narrative

Supplemental documentation.Changed/additional information added.D9 device available for evaluation -yes, received 6/29/2021.G6 type of report - follow-up.H2 if follow-up what type? additional information, device evaluation.H3 device evaluated by manufacturer - yes, evaluation summery attached.H6 type of investigation- 10.H5 investigation conclusion - zcd00005/defect confirmed: unknown responsible party h10 investigation report reads as follows: 07/09/2021 13:42:07 cst (brallo) "material number: mds86800xws, sample and/or photo provided? sample (quantity provided: 1 ea).Investigation conclusion / root cause: we received 1 ea rollator with the item number of mds86800xws with the lot number of 88520030002 in used condition.Inspected the brakes and they seemed to be functioning properly.When the brake was set, the rear wheels would not continue to rotate.The backrest attached and detached with a slight struggle.It appears that the backrest holsters are slightly bent.The seat upholstery appears to be in used condition with a few minor scratches present.The frame itself has multiple scratches and dents present, which are likely to be caused by impact.The folding mechanism functioned properly at the time of inspection.It allowed the rollator to open and close with ease.All four wheels are covered with a significant amount of dirt, grime, and hair.Based on the overall condition of the rollator it is undetermined what type of maintenance has been performed.Upon further investigation of the sample, it was discovered that the front right wheel was slightly bent after the product was fully assembled.Investigated this issue a little bit further and discovered that the caster stem was significantly bent.Given the information that was provided in the complaint, and the evidence provided with the physical sample, the root cause of this issue is unknown.The customer complaint has been confirmed.The division will monitor through trending.".

Event Description

It was reported, the right wheel collapsed and end-user fell backwards on pavement striking his right shoulder and the back of his head.End-user transported to the emergency room (er).

• Type of Device: ROLLATOR, BARIATRIC, BASIC STEEL
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 12061986
• MDR Text Key: 261227662
• Report Number: 1417592-2021-00108
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 07/20/2021

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: MDS86800XWS
• Device Lot Number: 88520030002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Initial Date Manufacturer Received: 06/21/2021
• Initial Date FDA Received: 06/24/2021
• Supplement Dates Manufacturer Received: 06/21/2021
• Supplement Dates FDA Received: 07/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 166