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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TEVA PHARMACEUTICALS USA PARAGARD DEVICE INTRAUTERINE

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TEVA PHARMACEUTICALS USA PARAGARD DEVICE INTRAUTERINE Back to Search Results
Model Number PARAGARD T380A
Event Date 01/09/2015
Event Type  malfunction  
Event Description
Iud was removed per patient request with ease. Shaft of device just partially covered by cooper coils(~2/3) of shaft.
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manufacturer response for paragard iud t380a, (brand not provided) (per site reporter).
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leadership is in contact with rep for resolution.
 
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Brand NamePARAGARD
Type of DeviceDEVICE INTRAUTERINE
Manufacturer (Section D)
TEVA PHARMACEUTICALS USA
1090 horsham rd
north wales PA 19454
MDR Report Key4501172
MDR Text Key5442351
Report Number4501172
Device Sequence Number1
Product Code UNK
Reporter Country CodeUS
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received01/30/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPARAGARD T380A
Device Lot Number508003
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/30/2015
Event Location Other
Date Report to Manufacturer02/10/2015

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