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

Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/16/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
The paragard copper iud placed in 2011 was removed a few months ago with one arm breaking off in uterine wall.

• Brand Name: PARAGARD
• Common Device Name: INTRAUTERINE, DEVICE, CONTRACEPTIVE
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 8362454
• Report Number: 8362454
• Device Sequence Number: 10446566
• Product Code: HDT
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• 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: 7 YR
• Event Location: Other
• Date Report to Manufacturer: 02/21/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/22/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Date Report Sent to FDA: 02/13/2019