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

Catalog Number MDS86800XW

Device Problem Break (1069)

Patient Problem Head Injury (1879)

Event Date 06/07/2023

Event Type  Injury  

Event Description

According to the customer, when walking the "wheel went into the sidewalk" causing him to "flip over" and hit his "head".

Manufacturer Narrative

According to the customer, when walking the "wheel went into the sidewalk" causing him to "flip over" and hit his "head".The customer reported they went to the hospital to be treated for the "head injury".No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.No additional information is available.It has been determined that the reported event caused or contributed to serious injury, 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,X-WIDE,HEAVY DUTY,400 LBS.
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17260894
• MDR Text Key: 318556630
• Report Number: 1417592-2023-00277
• 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: 07/05/2023

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
• Device Lot Number: 88516080053
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/07/2023
• Initial Date FDA Received: 07/05/2023
• 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): Other