MAUDE Adverse Event Report: ETHICON INC. TENSION FREE VAGINAL TAPE - EXACT UNKNOWN PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Fever (1858); Hemorrhage/Bleeding (1888); Pain (1994); Urinary Retention (2119); Abdominal Distention (2601); Unspecified Kidney or Urinary Problem (4503); Unspecified Tissue Injury (4559)

Event Date 04/01/2023

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.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.H6 component code: g07002 ¿ device not returned.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Related events captured via 2210968-2023-06088.Citation: modern obstet gynecol progress april 2023 vol.32 , no.4.

Event Description

Title: long-term follow-up of modified laparoscopic high sacral ligament suspension for mid-pelvic prolapse the objective of this study is to evaluate the long-term effect of modified laparoscopic high sacral ligament suspension in patients with middle pelvic prolapse.Between november 2017 to december 2020, 88 patients with pelvic prolapse who underwent laparoscopic high sacral ligament suspension and pubis cervical fasciitis repair were included in the study.The mean age of the patients was 54.34 ± 9.02 years and a mean body mass index 23.89 ± 3.10 kg/m2.Hysterectomy was performed in 71 cases, posterior colporrhaphy in 26 cases, perineal body repair in 5 cases, burch operation in 13 cases, and tvt-e operation using gynecare tvt exact (ethicon) in 3 cases.Repair of pubocervical fascia was performed using 2-0 ethibond (ethicon) non-absorbable suture in 32 cases while a competitor suture (manufacturer: gore) was used in 56 cases.The patients were followed up at 6 and 12 months after operation, and once a year after 1 year.The reported complications included fever (n=?), abdominal distension (n=?), urinary retention (n=?), postoperative recurrence (n=?), pelvic pain (n=?), acute urinary problems (n=?), stitch exposure with vaginal bleeding (n=?), pelvic prolapse (n=?) and intraoperative bladder injury (n=?).In conclusion, for middle pelvic prolapse, modified laparoscopic high sacral ligament suspension can achieve anatomical improvement and effectively improve the quality of life.

• Brand Name: TENSION FREE VAGINAL TAPE - EXACT UNKNOWN PRODUCT
• 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 Key: 17604065
• MDR Text Key: 321754062
• Report Number: 2210968-2023-06089
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K132054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female