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.
|
|
Search Alerts/Recalls
|
|
|