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U.S. Department of Health and Human Services

Medsun Reports
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Type of Device:
device, intrauterine
Device Brand Name:
ParaGard
Device Manufacturer's Name:
TEVA PHARMACEUTICALS USA
Date of this Report:
(mm/dd/yyyy)
07/17/2014
Describe the Event
or Problem:
Follow-up recommended for reports 4500150000-2014-8014, -8015, -8016, and -8017. Hospital reports 4 incidents where device fractured upon removal. Three of the four had devices well under expected lifespan. Hospital's incidents represent a large increase in reporting for this device.
the device(s) may have
caused or contributed to:
Not applicable
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