MAUDE Adverse Event Report: MENARINI HOUSE DEFINISSE THREADS HAPPY LIFT TREATMENT -MENARINI; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abscess (1690); Bruise/Contusion (1754); Pain (1994); Deformity/ Disfigurement (2360); Post Operative Wound Infection (2446); Swelling/ Edema (4577)

Event Date 06/07/2022

Event Type  Injury  

Event Description

Hi, i am writing this message to report adverse event happened to my mom after definisse threads treatment.On 3rd july, she underwent definisse threads happy lift treatment in presence of doctor dr (b)(6) ((b)(6) https://g.Co/ kgs/6rrvuj)) by some other doctors.Patient details gender-female age-58 years.After 10 days of treatment she starting having boil on her face.There was persistent pain after the treatment and lumps occurred on face.We contacted doctor regarding the same and suggested to take antibiotics and painkillers but the condition of the patient was worsening day by day.Her face swelled, boils occurred and there were bruising marks on face, lumps and pain.Doctor advised to come to his clinic, my mom visited his clinic.She went to doctor on 21st july, doctor removed a portion of thread from her face and did not provide any future treatment.There were boils occurring in other part of face also but doctor said things will get better and ignored the lumps and boils which were occurring on other part of her face.She continued suffering due to pain and bruises increased after that also and more boils started appearing on face.Now doctor again suggested to come to his clinic for further follow up.We again went to doc on 9th aug and doc injected some injection at affected site.This time she requested to remove the threads as she was going through lots of pain but doctor refused to do so and injected some injection (no information was provided about what he has injected and what has happened to her face).She again went to doctor in third week of aug and doctor again injected any injection.Even after continuously visiting to doctor things were not getting resolved.Her condition is getting worse.She has marks, swelling, boils, lumps and pain on her face.We again contacted to other members of menarini team, this time they contacted some other doctor on 24th aug.Doctor said that its an bacterial infection and antibiotics for long time needs to be taken to resolve this.We have been visiting to dr (b)(6) for the same but due to his negligency condition worsened.Now we went to another doctor for second opinion.Doctor said this infection happened sterility was not maintained during the procedure and as the infection is worsened it may become tumor/skin tuberculosis.A minor procedure turned into nightmare because of negligency of doctors.Even before the procedures no pros and cons of the procedure were explained.This practice is highly unethical and is dangerous.My mom has been suffering from more then 2 months and still things are not resolved as infection spreaded.It is so unfortunate for her to go through this trauma and nothing about any side effects was informed before the treatment.My moms face looks so bad and ugly due to this treatment.I request to take appropriate action in order to avoid any further harassment which she has been going through from more then 2 months.Reason for use: face lift-aging.

Event Description

Additional information received from the reporter for report mw5111816 on 11/07/2022.Now we went to another doctor for a second opinion.Doctor said this infection happened sterility was not maintained during the procedure and as the infection is worsened it may become tumor/skin tuberculosis.A minor procedure turned into a nightmare because of negligence of doctors.Even before the procedures no pros and cons of the procedure were explained.This practice is highly unethical and is dangerous.My mom has been suffering for more than 4 months and still things are not resolved as infection spreaded.It is so unfortunate for her to go through this trauma and nothing about any side effects was informed before the treatment.My mom's face looks so bad and ugly due to this treatment.I request to take appropriate action in order to avoid any further harassment which she has been going through for the last 4 months.We then went to (b)(6) as her condition was not resolving.Doctors of (b)(6) did some tests to rule out the real cause.In the biopsy it's showing multiple findings, they have started treatment but still not sure if my mother will respond to the treatment or not.If she will not respond to the treatment she might have to go for debridement to remove all the traces of the thread which is again a very critical process and will further increase marks on my mother's face.Please find emails and photos for your reference.Hoping for urgent action against such unethical practices in order to avoid harassment and important medical conditions.

• Brand Name: DEFINISSE THREADS HAPPY LIFT TREATMENT -MENARINI
• Type of Device: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): MENARINI HOUSE; mercury park, wycombe line; wooburn green, buckinghamshire HP10 OOH; UK HP10 OOH
• MDR Report Key: 15328155
• MDR Text Key: 299080938
• Report Number: MW5111816
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 08/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: ANTI HYPERTENSIVE; ANTI-ARITHRITIS; THYROID DRUGS
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Race: Asian