MAUDE Adverse Event Report: ENDOMETRIAL ABLATION

Device Problem Insufficient Information (3190)

Patient Problems Dyspnea (1816); Menstrual Irregularities (1959); Sleep Dysfunction (2517); Weight Changes (2607)

Event Date 06/10/2014

Event Type  Injury  

Event Description

After the ablation she experienced weight gain of fifteen pounds, difficulty breathing, insomnia and continous vaginal spotting.She has almost continuous menstruation now.

• Brand Name: ENDOMETRIAL ABLATION
• Type of Device: ENDOMETRIAL ABLATION
• MDR Report Key: 5130034
• MDR Text Key: 27625626
• Report Number: MW5056852
• Device Sequence Number: 1
• Product Code: HHR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR