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

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

• Brand Name: PARAGARD
• Type of Device: DEVICE, INTRAUTERINE
• Manufacturer (Section D): TEVA PHARMACEUTICALS USA; 1090 horsham rd; north wales PA 19454
• MDR Report Key: 3979376
• Report Number: 3979376
• Device Sequence Number: 1
• Product Code: HDT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/17/2014

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: Physician
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/17/2014
• Event Location: Other
• Date Report to Manufacturer: 08/05/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/17/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1