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U.S. Department of Health and Human Services

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

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ETHICON INC. TVT EXACT RETROPUBIC SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC Back to Search Results
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).
 
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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 Key18876569
MDR Text Key337344467
Report Number2210968-2024-02818
Device Sequence Number1
Product Code OTN
UDI-Device Identifier10705031062375
UDI-Public10705031062375
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K132054
Number of Events Reported1
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/31/2015
Device Catalogue NumberTVTRL
Device Lot Number3783294
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/20/2024
Initial Date FDA Received03/11/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/23/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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