MAUDE Adverse Event Report: ETHICON INC. TVT EXACT RETROPUBIC SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Model Number TVTRL

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

Patient Problems Purulent Discharge (1812); Pain (1994); Discomfort (2330); Post Operative Wound Infection (2446)

Event Date 01/09/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent a gynecological procedure on (b)(6) 2022 and mesh was implanted for pelvic organ prolapse and mixed urinary incontinence.On (b)(6) 2023, moderate post op wound infection was noted and reported as unlikely related to the study event.The patient experienced severe discomfort, pain and heavy discharge in perineum and augmentin for 10 days was prescribed.The patient no longer has any signs of infection and does not have any complaints about the procedure.Additional information was requested.

Manufacturer Narrative

(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information was requested and the following was obtained: please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure.Age:49 , women , 51 kg , 20.0 bmi.The diagnosis and indication for the index surgical procedure? pelvic organ prolapse and mixed urinary incontinence.Were any concomitant procedures performed? anterior ¿ posterior repair + perineorrhaphy + cystoscopy.Other relevant patient history/concomitant medications? no.Please describe the patient manifestations of the reported infection (location, severity, appearance, systemic or local infection).Patient manifestation of the reported infection : severe discomfort ¿ pain and heavy discharge in perineum.Physical exam of the infectious area ( (b)(6) 2023) : her vulvovaginal area seems to have good support, no mesh exposure, no bleeding however her perineal incision shows signs of infection with purulent discharge upon pressure.Were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? no.Did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? patient received preoperative 2 gr cefazolin iv for surgical prophylaxis.Were cultures performed? if so, please provide the results.No.Please describe the drug therapy performed including medication name and results.Augmentin for 10 days was prescribed.Her symptoms were resolved and her physical exam was within normal limits at the visit which was performed on (b)(6) 2023.What is the physician¿s opinion as to the etiology of or contributing factors to this event? n/a.What is the patient's current status? she does not have any signs of infection and does not have any complaints about the procedure.Her last visit (visit 4) was performed on (b)(6) 2023.To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.H6 component code: g07002 ¿ device not returned.

Manufacturer Narrative

(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H6 additional information received: adverse event term: post op wound infection updated: relationship to primary study procedure: not related a manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.

• Brand Name: TVT EXACT RETROPUBIC SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17332617
• MDR Text Key: 319300248
• Report Number: 2210968-2023-05186
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031062375
• UDI-Public: 10705031062375
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: TVTRL
• Device Catalogue Number: TVTRL
• Device Lot Number: 3942619
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2022
• 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: 49 YR
• Patient Sex: Female
• Patient Weight: 51 KG