MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; ROLLATOR,BASIC,BURGUNDY

Catalog Number MDS86850E

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 12/19/2023

Event Type  Injury  

Event Description

According to the customer "the patient fell inside the hospital while walking" with their rollator.Per the customer they were already in the hospital when the fall occurred and received an "xray and ct".

Manufacturer Narrative

According to the customer "the patient fell inside the hospital while walking" with their rollator.Per the customer they were already in the hospital when the fall occurred and received an "xray and ct".Per the facility "there were serious injuries to the patients upper and lower extremities including lost tooth and other injuries" that were not specified.Per the customer there was a wire protruding from the right wheel which "caused additional damage to the patient's right ring finger".No additional information is available.The sample was requested for evaluation.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Type of Device: ROLLATOR,BASIC,BURGUNDY
• 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: 18506579
• MDR Text Key: 332807717
• Report Number: 1417592-2024-00026
• 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: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS86850E
• Device Lot Number: 05422080001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2023
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other