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

Catalog Number MDS86800XWS

Device Problem Break (1069)

Patient Problem Neck Pain (2433)

Event Date 11/12/2020

Event Type  Injury  

Manufacturer Narrative

It was reported the rollator front wheel broke off while end user was sitting on item and scooting backwards.End user fell and injured his neck and back.Phone call received from end user, who provided additional information related to this incident.Reporter states that on (b)(6) 2020 he was sitting on the rollator at the kitchen table and as he "scooted backwards to reach for something the front wheel broke off." end user reports he fell backwards hitting the back of his head on a curio cabinet, twisted his neck and hurt his back.End user reports his wife was able to assist him to his feet.End user reports he did not seek medical attention that day but did seek medical attention on (b)(6) 2020.End user states he went to (b)(6) emergency department (er) for complaints of back and neck pain.While at the er end user report's a cat scan was taken of his head, cervical and thoracic spine.Upon discharge, end user prescribed a muscle relaxer (methocarbamol) and advised to continue taking tylenol as needed.End user reports he is doing much better at this time.States, "he is just in need of a rollator." the sample is available for return and evaluation.Due to the reported incident, medical intervention 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 the rollator front wheel broke off while end user was sitting on item and scooting backwards.End user fell and injured his neck and back.

Manufacturer Narrative

Changed/additional information added.D9 device available for evaluation -yes, date returned to manufacturer - 12/2/2020.G6 type of report: follow-up.H3 device evaluated by manufacturer - yes, evaluation summary attached.H6 type of investigation: 10.H10 investigation report reads as follows, 12/3/2020, "we received one each of this xw rollator in used condition.The quality complaint indicates the customer was sitting on the rollator in his home and the front wheel broke off causing a fall.We did check this and immediately noticed the right front wheel has broken off.This may be due to a fractured fork stem bolt.The brakes worked ok including the lock down function and stops wheel rotation.The seat upholstery, backrest foam padding, handgrips, and wheels show signs of normal wear.The rest of the frame shows signs of wear including some scratches.Based on the condition of this rollator it is undetermined what type of maintenance has been performed.The root cause of this issue is unknown.The quality complaint has been confirmed.The sample will be held.Divisional quality assurance will continue to monitor via monthly and quarterly trending.".

Event Description

It was reported the rollator front wheel broke off while end user was sitting on item and scooting backwards.End user fell and injured his neck and back.

• Type of Device: ROLLATOR, BARIATRIC, BASIC STEEL,
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 10922902
• MDR Text Key: 218903986
• Report Number: 1417592-2020-00145
• 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: 12/07/2020

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: 88519110005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/30/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 163