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

Lot Number	511001
Medical Device Problem Codes	Break (1069); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Foreign Body In Patient (2687)
Date of Event	02/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Narrative from staff: patient had copper iud (intrauterine device) in for 10 years, thinks she is starting menopause symptoms.Patient tolerated removal well, but upon removal the iud was broken with both arms missing.Nurse practitioner was able to retrieve one of the arms but could not find the other arm.The nurse practitioner briefly tried to use the cytobrush to sweep the os but this was painful and seemed futile.Patient was referred to ob/gyn for removal and is scheduled.

• 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: 13847896
• Report Number: 13847896
• Device Sequence Number: 15781972
• Product Code: HDT
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2022
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/04/2022
• Report Date (Section F): 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Lot Number: 511001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 10 YR
• Event Location: Other
• Date Report to Manufacturer: 03/22/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/22/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 82 KG
• Date Report Sent to FDA: 03/04/2022