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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPERSURGICAL, INC. PARAGARD; DEVICE, INTRAUTERINE, CONTRACEPTIVE AND INTRODUCER
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COOPERSURGICAL, INC. PARAGARD; DEVICE, INTRAUTERINE, CONTRACEPTIVE AND INTRODUCER Back to Search Results
Model Number 512801
Medical Device Problem Codes Break (1069); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 07/31/2020
Type of Reportable Event Malfunction
Event or Problem Description
Patient had iud inserted six years ago and called the office after having four positive home pregnancy tests.Patient came into office and urine pregnancy test was done with a positive result.Patient was examined by doctor who did an ultrasound to see placement of iud.Ultrasound showed no intrauterine pregnancy seen and iud was in cervical canal.Doctor then removed iud and found that iud was broken.
 
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Brand Name
PARAGARD
Common Device Name
DEVICE, INTRAUTERINE, CONTRACEPTIVE AND INTRODUCER
Manufacturer (Section D)
COOPERSURGICAL, INC.
95 corporate drive
trumbull CT 06611
MDR Report Key10384231
Report Number10384231
Device Sequence Number3105781
Product Code HDT
Combination Product (Y/N)N
Initial Reporter StateMI
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2020
Reporter Type User Facility
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 08/06/2020
Report Date (Section F) 08/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Model Number512801
Device Lot Number513003
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Device Age6 YR
Event Location Other
Date Report to Manufacturer08/10/2020
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date08/10/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Date Report Sent to FDA08/07/2020
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