MAUDE Adverse Event Report: COLLEGE PARK INDUSTRIES, INC. ICON; EXTERNAL PROSTHETIC KNEE

Model Number	IC MPKA 1000
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Fall (1848)
Date of Event	09/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
College park will investigate the returned icon knee and report the findings.College park will continue to monitor the returns for trends.
Event or Problem Description
The patient was at a restaurant and she caught her toe and fell.Patient went to urgent care.She does not have any fractures, just bumps and bruises.

• Brand Name: ICON
• Common Device Name: EXTERNAL PROSTHETIC KNEE
• Manufacturer (Section D): COLLEGE PARK INDUSTRIES, INC.; 27955 college park dr; warren 48088
• Manufacturer (Section G): COLLEGE PARK INDUSTRIES, INC.; 27955 college park drive; warren MI 48088
• Manufacturer Contact: julie carver ; 27955 college park drive; warren, MI 48088 ; 5863542265
• MDR Report Key: 20181284
• Report Number: 1834241-2024-00002
• Device Sequence Number: 8298469
• Product Code: ISY
• UDI-Device Identifier: 00195411451081
• UDI-Public: 00195411451081
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 09/10/2024

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
• Operator of Device: Lay User/Patient
• Device Model Number: IC MPKA 1000
• Device Catalogue Number: IC MPKA 1000
• Device Lot Number: 08072024
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female