MAUDE Adverse Event Report: COOPERSURGICAL, INC. PARAGARD; DIAPHRAGM, CONTRACEPTIVE (AND ACCESSORIES)

Lot Number 512005

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/07/2022

Event Type  malfunction  

Event Description

Arm broke off paragard intrauterine device (iud) upon removal and remained in uterus.Pt will need additional ultrasound to assess location of broken retained iud arm.

• Brand Name: PARAGARD
• Type of Device: DIAPHRAGM, CONTRACEPTIVE (AND ACCESSORIES)
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate dr.; trumbull CT 06611
• MDR Report Key: 15469954
• MDR Text Key: 300458401
• Report Number: 15469954
• Device Sequence Number: 1
• Product Code: HDW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 512005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/08/2022
• Device Age: 9 YR
• Event Location: Other
• Date Report to Manufacturer: 09/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 13870 DA
• Patient Sex: Female