MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; ROLLATOR,STEEL,1/CS

Catalog Number CVS792519

Device Problem Material Twisted/Bent (2981)

Patient Problem Bruise/Contusion (1754)

Event Date 02/01/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported, "husband used the rollator one day, the product bent, and he fell and hurt himself." phone call placed to spouse of end-user.Reporter states, "the rollator was purchased from cvs health a few month ago and reports that on this particular date (reporter is unable to recall date of incident at this time) her spouse was using the rollator while walking down their front cement walkway." reporter states, "all of a sudden the right front leg just bent and my husband fell off the walkway between a large rock and a tree." reporter states, "he was injured pretty well." however, was unable to articulate his exact injuries.Reporter states, 911 was called and the end-user was taken to the nearest hospital.Reporter states, the end-user was examined by an md and believes an mri was completed to ensure he had no bleeding due to he was recently released from the hospital for a stroke suffered (b)(6) 2020.Reporter states, end-user continues to have physical therapy related to the stroke event but is recovering well walking with a walker and has full cogitative function (completing their taxes).Reporter states, end user was not admitted to the hospital but released later that day "with only a few bumps and bruises to his right knee and shoulder." reporter states the rollator is available for return and evaluation.Reporter is asking for a refund in the amount she paid (b)(6) (she believes the amount is (b)(6)) but no longer can locate the purchase receipt.Customer is not interested in a replacement rollator stating her spouse no longer uses a rollator only a walker.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

It was reported, "husband used the rollator one day and the product bent and he fell and hurt himself.".

Event Description

It was reported, "husband used the rollator one day and the product bent and he fell and hurt himself.".

Manufacturer Narrative

Changed/additional information added.D9 device available for evaluation -no.G6 type of report - follow-up.H2 if follow-up what type? additional information.H3 device evaluated by manufacturer - no, not returned to manufacturer.H6 type of investigation- n/a.H5 investigation conclusion -4315 cause/ zcd00006/unconfirmed defect.H10 investigation report reads as follows: investigation summary: investigation summary: 03/22/2021 21:51:15 cst."no sample was received.Without a physical sample, this cannot be confirmed to be a medline quality issue.Divisional qa performs trending on complaints received, and will initiate further investigation and/or supplier corrective action requests based on trending results.Should a sample be received, the complaint will be reopened and a full investigation will be conducted.".

• Type of Device: ROLLATOR,STEEL,1/CS
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 11396504
• MDR Text Key: 245121115
• Report Number: 1417592-2021-00023
• 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: 03/25/2021

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: CVS792519
• Device Lot Number: 8852004002
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/22/2021
• Initial Date FDA Received: 03/01/2021
• Supplement Dates Manufacturer Received: 02/22/2021
• Supplement Dates FDA Received: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 112