MAUDE Adverse Event Report: TEVA PHARMACEUTICALS USA PARAGARD; DEVICE, INTRAUTERINE, CONTRACEPTIVE

Lot Number	513002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/07/2016
Type of Reportable Event	Malfunction
Event or Problem Description
The iud made of copper broke apart in the patient.During out-patient surgery, the device was removed.

• Brand Name: PARAGARD
• Common Device Name: DEVICE, INTRAUTERINE, CONTRACEPTIVE
• Manufacturer (Section D): TEVA PHARMACEUTICALS USA; 1090 horsham rd.; north wales PA 19454
• MDR Report Key: 5515917
• Report Number: 5515917
• Device Sequence Number: 11969611
• Product Code: HDT
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Reporter Type: User Facility
• Type of Report: Initial
• Report Date (Section B): 03/09/2016
• Report Date (Section F): 03/09/2016

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: No Information
• Device Expiration Date: 01/01/2020
• Device Lot Number: 513002
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/09/2016
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 20 YR
• Date Report Sent to FDA: 03/09/2016