MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; ROLLATOR, EMPOWER, WHITE, MB

Catalog Number MDS86845W

Device Problem Material Twisted/Bent (2981)

Patient Problems Ambulation Difficulties (2544); Drug Resistant Bacterial Infection (4553)

Event Date 08/17/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported, the wheel bent on the rollator as the end user was walking and he fell.End user was taken to local emergency room and then admitted to the hospital.Phone call placed (b)(6), end user's caregiver and (reporter of this incident), who provided additional information in regards to this incident.Reporter states, this incident occurred tuesday (b)(6) 2021, sometime in the mid-afternoon (3-5pm).Reporter believes the end user was walking with the rollator from his bedroom to the bathroom and fell somewhere in-between.Reporter states, end user was transported to the local emergency room.Reporter states, she is unclear of what tests were completed but, reports the end user was admitted to the hospital that day and then transferred to a rehab facility (b)(6) 2021.Ken hinds (end user) later revealed the reason for admission to the hospital is that "re-current (b)(6)" had returned and he was being treated with iv antibiotics and due to the side effects of the (b)(6) and difficulty with ambulation-needed rehabilitation.(b)(6) mccown who provided additional information in regards to end users prior health history.(b)(6) reports, end user was involved in a car accident, years ago which resulted in an unresolved knee injury and the end user having to use an assistive device while ambulating.(b)(6) reports, end user is not interested in exchanging the rollator for the same rollator.End user would like to request a full refund in order to purchase a different "more stable" rollator.A full refund was approved by l.W.The sample is available for return and evaluation.The sample has not been received at the time this report was filed.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 wheel bent on the rollator as the end user was walking and he fell.End user was taken to local emergency room and then admitted to the hospital.

Manufacturer Narrative

Sample received 09/10/2021.The customer returned the rollator for evaluation and the customer reported issue of a bent wheel was confirmed.The caster stem on the left front wheel appears to be significantly bent.A definitive root cause for the reported issue could not be determined at this time.No additional information is available.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Type of Device: ROLLATOR, EMPOWER, WHITE, MB
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093-2753 ; 2249311514
• MDR Report Key: 12442574
• MDR Text Key: 270490837
• Report Number: 1417592-2021-00165
• 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: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/11/2021

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: MDS86845W
• Device Lot Number: 86720120006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2021
• Initial Date Manufacturer Received: 08/17/2021
• Initial Date FDA Received: 09/08/2021
• Supplement Dates Manufacturer Received: 09/10/2021
• Supplement Dates FDA Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 113 KG