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

Lot Number 520004

Device Problem Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2022

Event Type  malfunction  

Event Description

Narrative from staff: issue with packaging.Upon opening the sterile package to hand to the surgical field, the paragard slid right out of the bottom of the package.When the package was opened to the scrub, she grabbed the end of the item in the package and upon pulling it out the iud (intrauterine device) is not attached to anything, so it slides right out of the package.Nurse had opened the package as the diagram stated but the iud portion is not hooked into the packaging.

• Brand Name: PARAGAURD
• Type of Device: DEVICE, INTRAUTERINE, CONTRACEPTIVE AND INTRODUCER
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 13847898
• MDR Text Key: 287618976
• Report Number: 13847898
• 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: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 520004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/04/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/22/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1