MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; ROLLATOR, SUPERLIGHT, RED

Catalog Number MDS86825SLR

Device Problem Break (1069)

Patient Problem Fall (1848)

Event Date 07/30/2023

Event Type  Injury  

Manufacturer Narrative

It was reported by the customer contact that on (b)(6) 2023 her husband was walking with the device when the wheel came completely off.This resulted in a fall.It was reported that due to the fall "cat scan and xrays" were done.No additional information was provided.A sample was requested to be returned for evaluation.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.

Event Description

Fall requiring xray and ct scan.

Manufacturer Narrative

Updated to indicate a sample was returned and evaluated.

• Type of Device: ROLLATOR, SUPERLIGHT, RED
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17652079
• MDR Text Key: 322306067
• Report Number: 1417592-2023-00357
• 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,Followup
• Report Date: 08/30/2023

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 Catalogue Number: MDS86825SLR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/02/2023
• Initial Date FDA Received: 08/30/2023
• Supplement Dates Manufacturer Received: 08/02/2023
• Supplement Dates FDA Received: 10/27/2023
• 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