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

Device Problem Migration (4003)

Patient Problems Abscess (1690); Erosion (1750); Hemorrhage/Bleeding (1888); Inflammation (1932); Abnormal Vaginal Discharge (2123)

Event Date 01/01/2020

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.To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.H6 component code: g07002 ¿ device not returned.

Event Description

It was reported that a patient underwent a sling procedure on (b)(6) 2014 and mesh was implanted.Since 2020, the patient has experienced blood loss and chronic foul-smelling discharge which was diagnosed as visible and palpable urethral erosion of prosthetic material exiting through the urinary meatus.Consultation on (b)(6) 2024 found there is a trans urethral strip with vaginal erosion.The prosthetic material exits through the urinary meatus and is palpable.There is a chronic discharge.A bacteriological sample was taken and antibiotic therapy was started for three weeks.There is an indication for resection of the prosthetic material.This involves a trans obturator band.The material can be removed up to the obturated foramen.It is not necessary to remove it beyond the obturated foramen if there is no infection that has spread along the material.Surgery is scheduled on (b)(6) 2024 under general anesthesia.Pelvic mri performed on (b)(6) 2024 found inflammatory remodeling of the lower third of the urethra in t2 hypersignal and loss of urethral zonal anatomy.Abscessed collection centered on the lower third of the urethra, extending over a height of 14 mm, 6 mm transverse and anteroposterior.The patient's present condition is urethral erosion of the band, creating inflammatory remodeling of the urethra and loss of urethral zonal anatomy and abscessed collection centered on the lower third of the urethra.No further information is available as the reporter contact details were not disclosed.

• Brand Name: TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD
• 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: 18950354
• MDR Text Key: 338251857
• Report Number: 2210968-2024-03300
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K033568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial

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: 03/13/2024
• Initial Date FDA Received: 03/21/2024
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention