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

Lot Number	512005
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/07/2022
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: DIAPHRAGM, CONTRACEPTIVE (AND ACCESSORIES)
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate dr.; trumbull CT 06611
• MDR Report Key: 15469954
• Report Number: 15469954
• Device Sequence Number: 4570866
• Product Code: HDW
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/08/2022
• Report Date (Section F): 09/08/2022

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: 512005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 9 YR
• Event Location: Other
• Date Report to Manufacturer: 09/23/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/23/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Date Report Sent to FDA: 09/08/2022