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

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/16/2018

Event Type  Injury  

Event 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
• Type of Device: INTRAUTERINE, DEVICE, CONTRACEPTIVE
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 8362454
• MDR Text Key: 136917500
• Report Number: 8362454
• Device Sequence Number: 1
• Product Code: HDT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/13/2019
• Device Age: 7 YR
• Event Location: Other
• Date Report to Manufacturer: 02/21/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/22/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 10585 DA