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

Catalog Number MDS86850ES

Device Problem Patient Device Interaction Problem (4001)

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

Event Date 06/22/2022

Event Type  Injury  

Manufacturer Narrative

According to the customers spouse on (b)(6) 2022 the customer self-propelled from the table and fell backwards hitting their head on the floor.Per the spouse the following day after having issues getting out of bed, an ambulance was called and he was admitted to the hospital with a 'broken neck'.Per the spouse he had surgery on 6/25 to 'work on his neck and existing brain tumor,' and as of 6/28 the he is in an intensive care unit.The device is available but will not be returned for evaluation.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 customers spouse on (b)(6) 2022 the customer self-propelled from the table and fell backwards hitting their head on the floor.Per the spouse the following day after having issues getting out of bed, an ambulance was called and he was admitted to the hospital with a 'broken neck'.

• Type of Device: ROLLATOR,BASIC,STEEL,6",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: 15043450
• MDR Text Key: 296077471
• Report Number: 1417592-2022-00105
• 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: 07/18/2022

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: MDS86850ES
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/24/2022
• Initial Date FDA Received: 07/18/2022
• 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 Sex: Male