MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; ROLLATOR,X-WIDE,HEAVY DUTY,400 LBS.

Catalog Number MDS86800XW

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/20/2022

Event Type  Injury  

Manufacturer Narrative

According to the customer on (b)(6) 2022 he was pushing his rollator and went to use the brakes, and the breaks didn't hold.Per the customer he fell to the ground and experienced an exacerbation of his existing lower extremity wounds, and has required additional wound care and antibiotic treatment.Per the customer he has existing health issues which has led to excess fluid buildup and wounds on both of his legs.The device is available but the customer will not return it for evaluation.The customer was informed that he should no longer use the device, due to safety concerns.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

According to the customer on 07/20/22 he was pushing his rollator and went to use the brakes, and the breaks didn't hold.Per the customer he fell to the ground and experienced an exacerbation of his existing lower extremity wounds, and has required additional wound care and antibiotic treatment.

• Type of Device: ROLLATOR,X-WIDE,HEAVY DUTY,400 LBS.
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 15411723
• MDR Text Key: 299784724
• Report Number: 1417592-2022-00164
• 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
• Report Date: 09/13/2022

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?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS86800XW
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/31/2022
• Initial Date FDA Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 159 KG