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

Device Problems Break (1069); Component Missing (2306); Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 12/17/2018

Event Type  malfunction  

Event Description

On removal, iud found to be missing an arm.Arm retrieved.Unknown if arm broke prior to or during removal.

• Brand Name: PARAGARD IUD
• Type of Device: DEVICE, INTRAUTERINE, CONTRACEPTIVE AND INTRODUCER
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 8304573
• MDR Text Key: 135006130
• Report Number: 8304573
• 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: 12/31/2018

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: No Information
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/31/2018
• Event Location: Other
• Date Report to Manufacturer: 02/05/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 12410 DA
• Patient Weight: 59