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

Catalog Number TVTRL

Device Problem Migration (4003)

Patient Problems Erosion (1750); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Incontinence (1928); Unspecified Infection (1930); Memory Loss/Impairment (1958); Pain (1994); Rash (2033); Tinnitus (2103); Urinary Frequency (2275); Prolapse (2475)

Event Date 06/22/2016

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.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) 2014 and mesh was implanted.The patient reported not knowing the pain and immune/allergy responses were due to the medical device.The patient had mon pubis pulling and pain, pain in lower back, right thigh and leg within months of the initial surgery.The patient further reported experiencing unexplained rashes, psoriasis, hair loss, continual thrush, regular urinary tract infection symptoms, continence issues, brain fog and memory issues.The patient also experienced bleeding in (b)(6) 2016 and vaginal erosion was found.A revision was performed on (b)(6) 2018.The patient contracted staph and was given 7 days of in hospital iv antibiotics & a further 6 weeks of oral antibiotics.The implant was tested and returned a positive finding of candida and staph.The patient saw their general physician on a regular basis, had ultrasounds to find cause of pubic pain, had acupuncture, was put on opioids to manage pain, took medication for overactive bladder, permanent candida die off medication, was sent to counselling with a psychologist and prescribed antidepressants.The patient now needs continence products and has bladder and vaginal prolapse.No further information is available as reporter details have not been disclosed (confidential).

• 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: 18876569
• MDR Text Key: 337344467
• Report Number: 2210968-2024-02818
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031062375
• UDI-Public: 10705031062375
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K132054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Catalogue Number: TVTRL
• Device Lot Number: 3783294
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2014
• 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