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

Model Number 810081

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

Patient Problems Injury (2348); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.(b)(4) submitted for adverse event which occurred on (b)(6) 2014.Mwr-17072020-0000767785 submitted for adverse event which occurred on (b)(6) 2014.Mwr-17072020-0000767786 submitted for adverse event which occurred on (b)(6) 2015.Mwr-17072020-0000767791 submitted for adverse event which occurred on (b)(6) 2015.Mwr-17072020-0000767794 submitted for adverse event which occurred on (b)(6) 2016.Mwr-17072020-0000767796 submitted for adverse event which occurred on unknown date.

Event Description

It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2010 and mesh was implanted, due to stress urinary incontinence.It was reported that the patient underwent a vaginal hysterectomy; bilateral salpingooophorectomy and placement of mesh on (b)(6) 2014.It was reported that the patient experienced a vaginal mass on (b)(6) 2014 and underwent excision and removal of the mass and over-sew of vaginal cuff defect with electrocautery of granulation tissue site.It was reported that the patient underwent mesh removal surgery and cystoscopy on (b)(6) 2015.It was reported that the patient underwent urethral bulking with macroplastique on (b)(6) 2015.It was reported that the patient underwent urethrolysis, suburethral sling removal and right paravaginal defect repair on (b)(6) 2016.It was reported that the patient underwent pudendal nerve blocks on (b)(6) 2016, on (b)(6) 2016, on (b)(6) 2016, on (b)(6) 2017 and on (b)(6) 2017.It was reported that the patient underwent colpopexy, paravaginal repair pudendal nerve black and placement of retropublic sling, due to her 3rd degree cystocele and 90 degree rotation of her urethra.No additional information was provided.

• Brand Name: GYNECARE TVT OBTURATOR
• 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: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 10313589
• MDR Text Key: 200799232
• Report Number: 2210968-2020-05376
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031000346
• UDI-Public: 10705031000346
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2010
• Device Model Number: 810081
• Device Catalogue Number: 810081
• Device Lot Number: 3379937
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR