MAUDE Adverse Event Report: INTRAUTERINE DEVICE (IUD); REMOVER, INTRAUTERINE DEVICE, CONTRACEPTI

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fatigue (1849); High Blood Pressure/ Hypertension (1908); Anxiety (2328); Depression (2361); Abdominal Cramps (2543)

Event Date 07/07/2022

Event Type  Injury  

Event Description

Caller stated that she has been using intrauterine device (iud) for about three months.Lately she started experiencing reactions which include extreme fatigue, severe abdominal cramping, new depression, anxiety and high blood pressure.She stated she never had this symptoms before the use of the device.

• Brand Name: INTRAUTERINE DEVICE (IUD)
• Type of Device: REMOVER, INTRAUTERINE DEVICE, CONTRACEPTI
• MDR Report Key: 15028909
• MDR Text Key: 296100037
• Report Number: MW5110900
• Device Sequence Number: 1
• Product Code: HHF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 22 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White