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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

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ETHICON INC. PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Pain (1994)
Event Date 12/24/2020
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4).   to date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.  event related to prolift pelvic floor repair in (b)(6) 2010 reported via mw # 2210968-2021-02704.Event related to the tvt-obturator in (b)(6) 2010 reported via mw # 2210968-2021-02705.Event related to prolift pelvic floor repair in (b)(6) 2014 reported via mw # 2210968-2021-02706.Event related to the tvt-obturator in (b)(6) 2014 reported via mw # 2210968-2021-02707.Event related to prolift pelvic floor repair in (b)(6) 2016 reported via mw # 2210968-2021-02708.Event related to the tvt-obturator in (b)(6) 2016 reported via mw # 2210968-2021-02709.Event related to prolift pelvic floor repair on (b)(6) 2018 reported via mw # 2210968-2021-02710.Event related to the tvt-obturator on (b)(6) 2018 reported via mw # 2210968-2021-02711.Event related to prolift pelvic floor repair on (b)(6) 2020 reported via mw # 2210968-2021-02712.Event related to the tvt-obturator on (b)(6) 2020 reported via mw # 2210968-2021-02713.Event related to prolift pelvic floor repair on (b)(6) 2021 reported via mw # 2210968-2021-02714.Event related to the tvt-obturator on (b)(6) 2021 reported via mw # 2210968-2021-02715.
 
Event Description
It was reported that a patient underwent a sling procedure for prolapsus on (b)(6) 2010 and the mesh was implanted.It was reported that the patient experienced discomfort with frequent sensation of urinating.In (b)(6) 2010, the surgeon planned to give the patient a surgical trimming and conducted it in (b)(6) 2010.The patient started to have urinary tract infection in october 2010 and the surgeon believed it to be from vaginal droughts.In 2013, the patient experienced more frequent urinary tract infections and had a cystoscopy.The surgeon concluded that everything was normal, and the patient¿s burns always come from vaginal dryness so a new treatment was given.The patient expressed that pains have been coming since the operation.In (b)(6) 2014, the patient experienced more infections and urinary frequency.The patient was hospitalized for pyelonephritis and had a urethrocystoscopy.The patient was given oroken and monuril for prevention.In (b)(6) 2016, a uro-scanner was planned, and doctor suggested (uracyst): 8 injections of this product into the bladder.The patient urinary tract infections calmed down, but the patient still had vaginal burns and discharges electric at the anus.A consultation was done in which prescription of a new treatment for the burns was given.In (b)(6) 2017, the patient¿s urinary tract infections returned.On (b)(6) 2017, the patient was sent to a new urologist that concludes that all the pain comes from the prosthesis and the bandage.The patient was advised to see the implant surgeon.A doctor consultation (b)(6) 2017 resulted in suspicion that patient¿s nerves might have been pinched during the procedure, and that the patient needed to see a neurologist, but there was no neurological problem.The doctor prescribed antibiotics and advised patient to an osteopath gynecologist.In (b)(6) 2017 the patient started sessions at the osteopath once a month until june 2018.The doctor felt something during the session in (b)(6) 2018.In (b)(6) 2018, the patient returned to dr.Who decided to remove the prosthesis on (b)(6) 2018.The day after the operation the doctor showed the patient the prosthesis and tells the patient that everything could not be removed and informed the patient that the pain could be more now than before the operation.The patient was advised to been by other doctors.The urinary tract infections subsided, but the vaginal burns and electric shocks in the anus became unbearable.The patient went hospital e where the gynecologist told the patient that she contracted lichen during the operation and that the patient burns came from there.The patient was prescribed a cortisone-based treatment for vaginal dryness.The patient stayed that way to modify the treatment for two years.In (b)(6) 2020, the patient went urgently to the hospital and received treatment for an inflammation in the uterus and was referred to another hospital.Three days later, the patient had very sharp contractions and the patient had an operation the same evening.The next day the doctor explained that it was impossible to open the cervix uterus, and a syringe was used to empty the patient¿s uterus, which was filled with blood.An urgent mri of scheduled due to the health crisis.They patient was advised three weeks later to remove the uterus and ovaries.The patient was operated on (b)(6) 2020.A week after the operation, burns and electric shocks began to return.On (b)(6) during a post-operative appointment, the patent was advised of a urinary tract infection and that all the pain comes from there.The patient took treatment for the urinary tract infection, but the burns and electric shocks became more unbearable.The patient will do an ecbu to prove that she no longer has a urinary tract infection but that the pain is still present.No additional information available.
 
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Brand Name
PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT
Type of Device
MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
Manufacturer (Section G)
ETHICON SARL-NEUCHATEL
puits-godet 20
neuchatel 2000
SZ   2000
Manufacturer Contact
elba bello
p.o. box 151, route 22 west
somerville, NJ 08876
9082182213
MDR Report Key11566687
MDR Text Key257882533
Report Number2210968-2021-02712
Device Sequence Number1
Product Code OTP
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K013718
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Other
Type of Report Initial
Report Date 02/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received02/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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