MAUDE Adverse Event Report: ETHICON INC. GYNECARE TVT W/PRLNE BLUE MESH 1 EACH; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number 810041B

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

Patient Problems Micturition Urgency (1871); Hematoma (1884); Incontinence (1928)

Event Date 08/22/2023

Event Type  Injury  

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: 1.Please provide lot number - lot# 3943465 2.Was there any associated medical or surgical intervention to treat any of the patient consequences? if so, please clarify.- observation only ¿ no intervention.3.What is the most current patient status? - 11/6/23 ¿ office visit: patient experiencing both stress and urge incontinence.U/a ¿ negative.Pelvic floor muscle contraction 3/5: reduced strength.Pelvic us and ct scan indicate hematoma; no ovarian mass on ct scan.Plan: repeat urodynamics in 3 months when hematoma resolved.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.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure name of index surgical procedure? the diagnosis and indication for the index surgical procedure? were any concomitant procedures performed? other relevant patient history/concomitant medications? has the incontinence changed from pre-surgery condition? (worse, better, or returned to the same) onset date/time of the incontinence from the initial procedure? please describe any medical intervention required to treat the incontinence including medication name and results.What is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? surgeon¿s name? 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.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.

Event Description

It was reported that a patient underwent a sling procedure on (b)(6) 2023 and mesh was implanted.On the same day, mild post-op hematoma was noted.At a office visit on 06-nov-2023, the patient was experiencing both stress and urge incontinence.U/a was negative, pelvic floor muscle contraction 3/5: reduced strength, pelvic us and ct scan indicate hematoma and no ovarian mass on ct scan.T he plan is to repeat urodynamics in 3 months when the hematoma has resolved.This event was reported as having a possible relationship with the study device and a causal relationship with the study procedure.Additional information has been 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: a3, a4, b7, e1 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 - 76 yr old female, weight 293.8, bmi 42.11.Name of index surgical procedure? - retropubic midurethral sling.The diagnosis and indication for the index surgical procedure? - stress urinary incontinence.Were any concomitant procedures performed? - posterior colporrhapy, repair rectocele; cystourethroscopy.Other relevant patient history/concomitant medications? - n/a has the incontinence changed from pre-surgery condition? (worse, better, or returned to the same) - not improved following surgery.Onset date/time of the incontinence from the initial procedure? - (b)(6) 2023 ¿ office visit (4 wks post-op): pt stated leakage has not improved.Please describe any medical intervention required to treat the incontinence including medication name and results.- plan: repeat urodynamics in 3 months or when hematoma is resolved.Pt may be suitable for intraurethral bulking injection (if sui) or interstim (if uui).What is the physician¿s opinion as to the etiology of or contributing factors to this event? - multifactorial including severe obesity, intrinsic sphincter deficiency and concomitant urge incontinence.What is the patient's current status? - office visit (b)(6) 2023: pelvic us and ct scan ((b)(6) 2023) indicates hematoma; no ovarian mass on ct scan.Having both urge and stress incontinence.Drinks 20 oz coffee/tea x 2 in the morning.Bladder ultrasound, 120cc ¿ most likely hematoma.Urinalyisis is negative.Plan: repeat urodynamics in 3 months or when hematoma is resolved.Pt may be suitable for intraurethral bulking injection (if sui) or interstim (if uui).

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.Updated information: adverse event term: post-op hematoma.End date : blank: 26 feb 2024.

• Brand Name: GYNECARE TVT W/PRLNE BLUE MESH 1 EACH
• 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: 18409785
• MDR Text Key: 331507968
• Report Number: 2210968-2023-10222
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031000322
• UDI-Public: 10705031000322
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012628
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 810041B
• Device Lot Number: 3943465
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2023
• 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: 76 YR
• Patient Sex: Female
• Patient Weight: 133 KG