|
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Hematoma (1884); Hernia (2240); Impaired Healing (2378); Swelling/ Edema (4577)
|
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.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: 842 j mod urol, vol.27 no.10 oct.2022.
|
|
Event Description
|
Title: therapeutic effect of different treatments on cryptorchidism in different locations in children.The objective of this study is to investigate the curative effects of different surgical methods in the treatment of cryptorchidism in children.During june 2018 to june 2020, a total of 216 children with cryptorchidism underwent surgery.The patients age ranged from 10 months to 12 years (median 3 years).The patients were divided into minimally invasive surgery group (n = 137) and traditional surgery group (n = 79).In the minimally invasive surgery group, 74 cases of scrotal cryptorchidism received scrotal incision, and 63 cases of peritoneal cryptorchidism received laparoscopic orchiopexy.The implants used were ethicon sutures.The following complications were reported as follows: minimally invasive surgery group (n=5) inguinal hernia, (n=9) hydrocele, (n=7) poor wound healing, (n=12) scrotal haematoma, conventional surgery group, (n=4) inguinal hernia, (n=2) hydrocele, (n=5) poor wound healing, and (n=3) scrotal haematoma.In conclusion, minimally invasive surgery is as safe and effective as traditional surgery, but it needs shorter hospital stay, which is conducive to day surgery and cosmetic results.
|
|
Search Alerts/Recalls
|
|
|