(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.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.Does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? which specific ethicon products have been used during the procedures (product code, lot number)? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? 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.(b)(4).The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: ndiaye et al.African journal of urology (2021) 27:156.Https://doi.Org/10.1186/s12301-021-00260-9.
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Title: hypospadias treatment by tubulated pedicled preputial island flap according to the duckett technique: single-center experience in sub-saharan africa.This retrospective study aims to evaluate the results of duckett¿s pedicled prepucial flap procedure for hypospadias treatment in a reference hospital in west africa.From january, 1st 2003 to december, 31st 2015, forty-one patients were included in our study with a mean age of 11 ± 8.5 years (extremes of 1.8 and 31 years).During surgery,a duplay procedure was added to the duckett procedure in three patients.One to two additional layers are placed on the neo-urethra, one of which constitutes the spongioplasty.The duplay technique was associated with this in some patients.This consists in tubularizing the urethral plate on itself from the ectopic orifice to the top of the glans after an incision on either side of it.This association is made in the very posterior forms to reduce the length of the foreskin used.Slowly absorbable sutures (pds¿, ethicon inc., johnson & johnson, issy-les-moulineaux, france) were used (4/0 or 5/0 in children, and 3/0 or 4/0 in adults).Reported complications included: (n=6) superinfection of the wound.(n=3) total suture lossening managed with complete suture release with only one case of sucess.(n=1) urethro-cutaneous fistula, had a successful repair by excision of the fistulous tract and closure of the defect using interrupted sutures of the urethral and cutaneous planes.(n=1) retraction of the neo-meatus,.(n=6) stenosis of the neo-meatus, treated by iterative dilation using hegar candles with satisfactory results.(n=2) proximal urethral stenosis, treated unsuccessfully with urethroplasty.(n=2) residual curvature (n=3) bad cosmetic result.Non-troublesome residual curvature and poor cosmetic results were simply monitored.(n=4) failure, after treatment of complications.It was concluded ,that the treatment of hypospadias with the duckett technique gives encouraging results, but with a high complication rate.It is a complex surgery carried out in non-optimal conditions.Wound infection is a major problem.It is, therefore, necessary to improve aseptic conditions in the operating theater and during post-operative care, but also to train urologists in this specialized surgery.
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