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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL

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ETHICON INC. TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Swelling (2091); Not Applicable (3189)
Event Type  Injury  
Manufacturer Narrative
(b)(4).This report is related to a journal article, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.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.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that ethicon product (tension free vaginal tape - obturator) involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon product involved? citation: gynecology 2015 · 48: 164-168; doi 10.1007/s00129-014-3515-9.(b)(4).
 
Event Description
It was reported via journal article: "title: complications following a suburethral sling operation".Author(s): a.R.Mothes · m.P.Radosa · i.B.Runnebaum.Citation: gynecology 2015 · 48: 164-168; doi 10.1007/s00129-014-3515-9.This case report aimed to present a (b)(6) female patient who underwent suburethral, transobturator sling implant using tvttm obsturator system (ethicon) for persistent second grade detrimental urinary incontinence.Postoperatively day 6, the patient exhibited renewed clinical swelling and redness on both inner thighs diagnosed as type 1 necrotizing fasciitis on histopathology.She was treated with removal of alloplastic materials (tvt) and relief incisions made in the proximal third of both inner thighs under continuous intravenous antibiotic treatment.Debridement and removal of necrosis were performed.Further treatment included four courses of debridement and therapy with vacuseal negative pressure wound dressings, the wound was closed with secondary sutures.Follow up monitoring at 4-week intervals revealed no local irritation.A microbial mixed infection in the operation area was proven to be the cause in the case presented.This corresponds with the causal link between enterococcal infection and necrotizing fasciitis.The location of the alloplastic materials in tvt implants in the area of the pelvic floor could possibly be seen as a risk factor.
 
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Brand Name
TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD
Type of Device
MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON SARL-NEUCHATEL
puits-godet 20
neuchatel
SZ  
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key7979686
MDR Text Key124319458
Report Number2210968-2018-76630
Device Sequence Number1
Product Code OTN
Combination Product (y/n)N
PMA/PMN Number
K033568
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation Other
Type of Report Initial
Report Date 09/21/2018
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
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/21/2018
Initial Date FDA Received10/18/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age56 YR
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