MAUDE Adverse Event Report: OSSUR HF ICEROSS COMFORT; LINER

Model Number I-540628

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Multiple Fractures (4519)

Event Date 06/01/2022

Event Type  Injury  

Event Description

As the patient was walking the prosthetic device broke and the patient fell to the floor.Resulting injuries are broken left femur and broken ribs.

• Brand Name: ICEROSS COMFORT
• Type of Device: LINER
• Manufacturer (Section D): OSSUR HF; grjothals 1-5; reykjavik, 110 ; IC 110
• Manufacturer Contact: katla axelsdottir ; grjothals 1-5; reykjavik, 110 ; IC 110
• MDR Report Key: 16239329
• MDR Text Key: 308065606
• Report Number: 3003764610-2023-00004
• Device Sequence Number: 1
• Product Code: ISS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: I-540628
• Device Catalogue Number: I-540628
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other