MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; ROLLATOR, EMPOWER, BLUE

Catalog Number MDS86845BM

Device Problem Defective Component (2292)

Patient Problems Eye Injury (1845); Pain (1994)

Event Date 11/17/2021

Event Type  Injury  

Manufacturer Narrative

It was reported by the end user that she was walking with the rollator and she held onto the device to help her bend down however when she tried to grab the rollator, the left brake was not locking so the rollator moved forward and she fell.The end-user called 911 and the paramedics took her to the local emergency department where she was assessed, admitted and hospitalized for one week.The end-user stated that she experienced a black eye and hurt shoulder however admission diagnosis is unknown at this time.After a one week hospitalization the end-user was taken to a rehabilitation facility for two weeks and was continued in physical therapy.The sample has not been returned to the manufacturer for evaluation.The end-user reported that she continues to use the device against manufacturer's instructions.No additional information is available.Due to the reported incident 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 by the end user that she was walking with the rollator and she held onto the walker to bend down however when she tried to grab the rollator, the left brake was not locking so the rollator moved forward and she fell.

Manufacturer Narrative

The sample was returned for evaluation 3/25/2022.Sample evaluation: the unit received was evaluated and it was discovered that the brakes lock and function correctly.The left side rear wheel shoe is somewhat bent inward, but still functional.A definitive root cause could not be determined.No additional information is available.Due to the reported incident 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.

• Type of Device: ROLLATOR, EMPOWER, BLUE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 13484800
• MDR Text Key: 285323911
• Report Number: 1417592-2022-00010
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/09/2022

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: MDS86845BM
• Device Lot Number: 86721040001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/10/2022
• Initial Date FDA Received: 02/08/2022
• Supplement Dates Manufacturer Received: 03/25/2022
• Supplement Dates FDA Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 64 KG