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

Lot Number 513002

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/07/2016

Event Type  malfunction  

Event Description

The iud made of copper broke apart in the patient.During out-patient surgery, the device was removed.

• Brand Name: PARAGARD
• Type of Device: DEVICE, INTRAUTERINE, CONTRACEPTIVE
• Manufacturer (Section D): TEVA PHARMACEUTICALS USA; 1090 horsham rd.; north wales PA 19454
• MDR Report Key: 5515917
• MDR Text Key: 40861517
• Report Number: 5515917
• Device Sequence Number: 1
• Product Code: HDT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 03/09/2016
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20 YR