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

Model Number	T380A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
When doctor removed iud, it broke.Arm of iud is still in patient.Patient was in car accident with pelvic injury in 2020.

• Brand Name: PARAGARD
• Common Device Name: DEVICE, INTRAUTERINE, CONTRACEPTIVE AND INTRODUCER
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 10384297
• Report Number: 10384297
• Device Sequence Number: 15561317
• Product Code: HDT
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2020
• Report Date (Section F): 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: T380A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 7 YR
• Event Location: Other
• Date Report to Manufacturer: 08/10/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 08/06/2020