MAUDE Adverse Event Report: COOPERSURGICAL, INC. PARAGARD; DEVICE, INTRAUTERINE, CONTRACEPTIVE AND INTRODUCER

Model Number 512801

Device Problems Break (1069); Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/31/2020

Event Type  malfunction  

Event 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.

• Brand Name: PARAGARD
• Type of Device: DEVICE, INTRAUTERINE, CONTRACEPTIVE AND INTRODUCER
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 10384231
• MDR Text Key: 202178297
• Report Number: 10384231
• Device Sequence Number: 1
• Product Code: HDT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/07/2020,08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 512801
• Device Lot Number: 513003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/07/2020
• Device Age: 6 YR
• Event Location: Other
• Date Report to Manufacturer: 08/10/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 12045 DA