MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; ROLLATOR,STEEL,KNOCK-DOWN

Catalog Number MDS86850ESKD

Device Problem Use of Device Problem (1670)

Patient Problem Fall (1848)

Event Date 05/01/2023

Event Type  Injury  

Manufacturer Narrative

According to the customer on (b)(6) 2023, "the brake on the right side will not hold" which caused the customer to fall while she was walking with the device.The customer reported family was able to assist her up after the fall.A week later she had an mri which revealed a fracture of l4.The customer reports pain.The device 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 with a fracture.

• Type of Device: ROLLATOR,STEEL,KNOCK-DOWN
• 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: 17182823
• MDR Text Key: 317724644
• Report Number: 1417592-2023-00259
• 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: 06/22/2023

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: MDS86850ESKD
• Device Lot Number: 88521080003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2023
• Initial Date Manufacturer Received: 05/26/2023
• Initial Date FDA Received: 06/22/2023
• 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