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U.S. Department of Health and Human Services

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

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TEVA PHARMACEUTICALS USA PARAGARD DEVICE, INTRAUTERINE, CONTRACEPTIVE Back to Search Results
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.
 
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Brand NamePARAGARD
Type of DeviceDEVICE, INTRAUTERINE, CONTRACEPTIVE
Manufacturer (Section D)
TEVA PHARMACEUTICALS USA
1090 horsham rd.
north wales PA 19454
MDR Report Key5515917
MDR Text Key40861517
Report Number5515917
Device Sequence Number1
Product Code HDT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 03/09/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/22/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/01/2020
Device Lot Number513002
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/09/2016
Device Age2 YR
Event Location Hospital
Date Report to Manufacturer03/09/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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