MAUDE Adverse Event Report: LUMENIS, LTD. FEMTOUCH; POWERED LASER SURGICAL

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Burning Sensation (2146); Heavier Menses (2666)

Event Date 07/14/2018

Event Type  Injury  

Event Description

I have three kids; (b)(6).Since delivering the last child i've suffered from an increasing level of incontinence.My obgyn suggested i do three sessions of femtouch, which she said is a laser that would help with the incontinence.My first session was on (b)(6) 2018.The next day the incontinence was worse and i had some bleeding and burning.Those symptoms lasted around 2 to 3 days.My next session was on (b)(6) and i had the exact same symptoms following.I was going to schedule my 3rd and final session but since (b)(6), i have been experiencing many other symptoms.I have a constant burning sensation, inside and out.It is debilitating and never goes away.Since then, i have also experienced an extremely heavy and bright red period that lasts twice as long.In (b)(6), i have never experienced anything like this.Most importantly the burning sensation has caused me to go to the dr 3 times since (b)(6).Each time, they did a uti test, all of which have come out negative.The last dr's appt they also did a yeast infection test and transvaginal ultrasound which also came out normal.Needless to say the burning hasn't gone away and has also affected my sex life.

• Brand Name: FEMTOUCH
• Type of Device: POWERED LASER SURGICAL
• Manufacturer (Section D): LUMENIS, LTD.
• MDR Report Key: 7752370
• MDR Text Key: 116233460
• Report Number: MW5078865
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/03/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Weight: 45