MAUDE Adverse Event Report: COOPERSURGICAL, INC. PARAGARD; DEVICE, INTRAUTERINE, CONTRACEPTIVE

Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/05/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
A paragard copper iud that was placed ten years ago was removed with the arm breaking off in the uterine wall.

• Brand Name: PARAGARD
• Common Device Name: DEVICE, INTRAUTERINE, CONTRACEPTIVE
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 8357239
• Report Number: 8357239
• Device Sequence Number: 2038472
• Product Code: HDT
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2019
• Reporter Type: User Facility
• Type of Report: Initial
• Report Date (Section B): 02/13/2019
• Report Date (Section F): 02/13/2019

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?: Yes
• Operator of Device: No Information
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 10 YR
• Event Location: Other
• Date Report to Manufacturer: 02/21/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Date Report Sent to FDA: 02/13/2019