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Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Fatigue (1849); Incontinence (1928); Pain (1994); Dizziness (2194)
Event Date 10/26/2017
Event Type  Injury  
Event Description
On (b)(6) 2017 i had a vaginal rejuvenation procedure performed.Towards the end of the procedure i experienced what felt like electricity running through my vaginal region.It was very painful and had the sensation of extreme heat.I yelled, jumped and the dr.Stated that she needed to put more jell on the tip.After the initial onset of the pain, i felt the heat, but the pain subsided.The procedure was being performed with a genevieve (viveve) laser.The traditional settings for this procedure is 110 pulses in a 30 min time frame.My procedure was being performed with a new, trial hand piece that used 220 pulse in a 60 minute time frame which was disclosed before the procedure.The procedure was completed and i left the facility.Later in the evening i was in a substantial amount of pain and tried otc medication for relief, to no avail.I contacted the facility the following day to see if this was normal and was told it was not and was instructed to come in for an evaluation.After the evaluation the dr.Stated the tissue inside my vagina was pink and appeared healthy.I was still in pain and she instructed me to continue with the tylenol, that she would contact the manufacturer.The doctor gave me her personal cell # and instructed me to contact her over the weekend if i was not feeling better.I did contact her and was not given relief.Unable to bear the pain, i went to my gynecologist for help.She evaluated me, said my tissue was pink and appeared to be healthy, stated she believed it was nerve damage, but could not be sure, this was not her field of expertise.She prescribed vaginal suppositories, which helped, but did not relieve the pain enough to be able to function.I again contacted the physician that performed the procedure who called in another vaginal suppository, these did not provided relief either.I contacted professionals of my previous employer, a medical laser manufacturer seeking their advice.I was told to request oral gabapentin and i did so.The medication did relieve the pain which had become extremely unbearable, but had side effects.I was very dizzy, equilibrium was off and i was very drowsy.In addition to those side effects, i also lost all feeling in my vagina including the urge or sensation to know when to urinate as well as sexual function.Taking into consideration i was unable to drive, i subsequently took time off from work to recuperate.I was told by the doctor that the "cryo" portion of the equipment had malfunctioned and was the cause of the incident.She did not know how to treat me and stated the manufacturer was not giving her the appropriate answers to her questions in order to treat me effectively.She could not tell me if my symptoms would be short term or long term.I requested information from the manufacturer, including but not limited to, was the equipment inspected by a trained and competent, certified engineer prior and or after the incident, what was their findings, has there been any other reported cases mirroring mine with this new hand piece, and if so, how were the injuries treated.Vivieve refused to answer my questions and insisted the equipment did not malfunction, leaving me to believe they were laying blame on the physician.They also stated that they had answered all of the doctors questions.The doctor as well as vivieve personnel were cc'd on the email.With the help of the same health care professionals from my previous employment, i weaned myself off of the gabapentin.As of date, i have not regained the sensations in my vagina and i am still experiencing urinary incontinence.I have requested from both the doctor and the manufacturer the mdr # as it is required for both of entities as medical professionals to report this type of incidents within 30 days and as of date i have not received the requested information.Therefore, in light of my injuries and lack of assistance from the individuals involved, i am self reporting.
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Brand Name
Type of Device
Manufacturer (Section D)
MDR Report Key7199857
MDR Text Key97774227
Report NumberMW5074608
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 01/15/2018
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 Health Professional
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/16/2018
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Disability;
Patient Age44 YR
Patient Weight77