MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; ROLLATOR, EMPOWER, BLUE

Catalog Number MDS86845BM

Device Problem Mechanical Problem (1384)

Patient Problems Bruise/Contusion (1754); Hip Fracture (2349)

Event Date 11/19/2023

Event Type  Injury  

Event Description

According to the customer, on (b)(6) 2023 her father-in-law was walking with the rollator when the "pin or screw by the wheel snapped in half causing the wheel to fall off and him to fall onto the floor".

Manufacturer Narrative

According to the customer, on (b)(6) 2023 her father-in-law was walking with the rollator when the "pin or screw by the wheel snapped in half causing the wheel to fall off and him to fall onto the floor".The customer reported he hit his "left side, arm, and head" on the floor and was taken to the emergency department where he was admitted.The customer reported there was "bruising" on his arm, a "lump" on his head, and a "hair line fracture" that was confirmed with a "cat scan".The customer reported he received "hydrocodone" for his pain and is in surgery to have "screws inserted" into his hip.Sample requested for return 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.

• Type of Device: ROLLATOR, EMPOWER, BLUE
• 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: 18344891
• MDR Text Key: 330803766
• Report Number: 1417592-2023-00502
• 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: 12/18/2023

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: MDS86845BM
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/20/2023
• Initial Date FDA Received: 12/18/2023
• 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