MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; ROLLATOR,BASIC,STEEL,6",BURGUNDY

Catalog Number MDS86850ES

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Pain (1994); Spinal Column Injury (2081)

Event Date 08/01/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that while end-user was walking in the kitchen using the rollator, a bolt from the rollator's handle came off.This reportedly resulted in the rollator's brakes not holding, the rollator becoming wobbly, and end-user falling onto the floor.The end-user added that she is hard of hearing and did not hear that the bolt came off.Two weeks after the incident, the end-user stated that she went to see a doctor due to worsening back pains and an mri was done, which revealed a new herniation.Laminectomy (surgical procedure) was reportedly recommended to be done.Per end- user, the doctor was unsure if the new herniation is related to the fall incident "but i (end-user) think it could have been from the fall".Of note, the end-user stated that she has chronic back issues and had back surgery in 2013.The rollator involved in this incident was received from end user's insurance two weeks prior to the incident.Due to the reported new herniated disk, the planned surgical procedure and in an abundance of caution, this medwatch is being filed.The sample has not been returned for evaluation.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that while end-user was walking using the rollator, a bolt from the rollator's handle came off resulting in end-user falling.

Manufacturer Narrative

The sample was returned for evaluation.The rollator was received in extremely used condition.Markings on the rollator's handles indicate that the handles were set at the highest setting.The returned rollator was received with only one height adjustment screw (other height adjustment screw fell off/missing, as previously reported).The height adjustment screw was missing the plastic curved washer.The threads on the height adjustment screw did not appear to be stripped and were able to thread into the thumbscrew without any issues.If the thumbscrew is left loose, it is possible that over time, the screw could have backed out of the frame resulting in the handle to suddenly drop.Since we did not receive the other height adjustment screw, the root cause for the reported issue of bolt falling out from the handle could not be determined.No other issues were observed with the push handles.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.

• Type of Device: ROLLATOR,BASIC,STEEL,6",BURGUNDY
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 9161350
• MDR Text Key: 170106398
• Report Number: 1417592-2019-00157
• 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: 11/04/2019

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: MDS86850ES
• Device Lot Number: O5418060001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Initial Date Manufacturer Received: 09/09/2019
• Initial Date FDA Received: 10/07/2019
• Supplement Dates Manufacturer Received: 09/09/2019
• Supplement Dates FDA Received: 11/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 57