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

Lot Number 511001

Device Problems Break (1069); Device Contamination with Chemical or Other Material (2944)

Patient Problems Failure of Implant (1924); Pain (1994); Foreign Body In Patient (2687)

Event Date 02/18/2022

Event Type  malfunction  

Event 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
• Type of Device: DEVICE, INTRAUTERINE, CONTRACEPTIVE AND INTRODUCER
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 13847896
• MDR Text Key: 287619071
• Report Number: 13847896
• 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: 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
• Device Operator: 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
• Date Report Sent to FDA: 03/04/2022
• Device Age: 10 YR
• Event Location: Other
• Date Report to Manufacturer: 03/22/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17885 DA
• Patient Sex: Female
• Patient Weight: 82 KG