MAUDE Adverse Event Report: ETHICON INC. GYNECARE TVT OBTURATOR W LASR; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number 810081L

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nerve Damage (1979); Pain (1994); Burning Sensation (2146); Ambulation Difficulties (2544); Not Applicable (3189); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).A review of the batch manufacturing records was conducted, and the batch met all finished goods release criteria for lot 3547876 and product code 810081l.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.The patient demographic info: age, weight, bmi at the time of index procedure other relevant patient¿s comorbidities? was there any deficiency or anomaly of the mesh? if yes, please describe it.When and how was the abscess diagnosed? patient symptoms manifestations of abscess (location, severity, appearance, systemic or local reaction)? what was a reason of vaginal part mesh (tvtobturator) removal? results and surgical findings of nerve decompression in january 2018? results and surgical findings of surgery in sept 30, 2019? were cultures performed for abscess? results? what is physician¿s opinion as to the etiology of or contributing factors to these events: nerve compression, abscess and drainage of an abscess? does the surgeon believe the mid urethral sling (tension free vaginal tape - obturator) caused pudendal nerve, cluneal neuralgia and maigne¿s syndrome? what is the patient's current status after mesh removal procedure?.

Event Description

It was reported that the patient underwent a sling procedure concurrently with cervix and uterus hysterectomy on (b)(6) 2011 and the mesh was implanted for urinary incontinence, after a failed reeducation.In 2014 the patient was diagnosed with bilateral pudendal neuralgia and right cluneal neralgia with sciatica.The patient experienced chronic neuropathic pain and general hypersensitivity.Overall, the patient's body was impacted with imbalance of the pelvis, myofascial syndrome, syndrome of maigne, significant gastric and defecation disorders, vaginal and urinary burns, anal tear feelings, coccyx and jaw luxation, cervical blockages, allodynia and pain at the groin, the gluteal fold, the pins, the right inner thighs and the right leg until the foot.The patient is unable to sit even if the gutted pillow, has limitation for walking, sleeping, eating, dressing up and daily gestures.The patient is known as disable person.The neurostimulation/ transcranial stimulation tens eco2, kinesitherapy osteo-etiopathy, acupuncture and hypnosis pains were performed by the care facility.In january 2018, the patient underwent a decompression of right pudental nerve procedure.Additional information has been requested.

• Brand Name: GYNECARE TVT OBTURATOR W LASR
• 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 ; SZ
• Manufacturer Contact: kara ditty-bovard ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 6107428552
• MDR Report Key: 9262489
• MDR Text Key: 167673762
• Report Number: 2210968-2019-89329
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031062306
• UDI-Public: 10705031062306
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K033568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2012
• Device Catalogue Number: 810081L
• Device Lot Number: 3547876
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention