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

Model Number PARAGARD T380A

Device Problem Component Missing (2306)

Patient Problem No Information (3190)

Event Date 03/26/2014

Event Type  malfunction  

Event Description

When iud removed, noticed one arm of the iud was missing.
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manufacturer response for paragard iud t380a, (brand not provided) (per site reporter).
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leadership working with rep to resolve.

• Brand Name: PARAGARD
• Type of Device: DEVICE INTRAUTERINE
• Manufacturer (Section D): TEVA PHARMACEUTICALS USA; 1090 horsham rd; north wales PA 19454
• MDR Report Key: 4500903
• MDR Text Key: 5352120
• Report Number: 4500903
• 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: 01/30/2015

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: Health Professional
• Device Model Number: PARAGARD T380A
• Device Lot Number: 805004
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/30/2015
• Event Location: Other
• Date Report to Manufacturer: 02/10/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/30/2015
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Weight: 91