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

Device Problem Migration (4003)

Patient Problems Adhesion(s) (1695); Autoimmune Disorder (1732); Erosion (1750); Hemorrhage/Bleeding (1888); Incontinence (1928); Nerve Damage (1979); Pain (1994); Urinary Tract Infection (2120)

Event Date 09/29/2012

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 gynecological procedure on (b)(6) 2012 and mesh was implanted.The patient reported, hours after the mesh was inserted the bladder was completely restricted (too tight).The patient was left with constant utis, home deliveries of catheters and enormous stress.The patient was told the mesh was too tight.It was cut in half then and the bladder was lifted.The patient further reported that the mesh had already eroded into the bladder and caused bleeding.Terrible pain continued and the patient saw a mesh removal consultant who said the mesh had eroded into the walls of the vagina, bowel and pubus muscle.The patient experienced autoimmune problems in the feet, esophagus and skin as the body was trying to attack the mesh.The patient underwent removal in two parts and stated the surgeries were long and complex.The patient had to have a bladder lift but due to nerve damage from the mesh and surgeries, the patient experienced double leakage and pain in the foot.The patient has since had to have a large adhesion removed due to surgeries and the mesh that was stuck to the bladder and bowel.The patient is still receiving treatment and has been referred to a neurologist.The patient continues to struggle with excruciating pain inside.No further information is available as the reporter contact details were not disclosed.

• Brand Name: TENSION FREE VAGINAL TAPE 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: 18758523
• MDR Text Key: 336002341
• Report Number: 2210968-2024-01668
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K974098
• 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

• Date FDA Received: 02/22/2024
• 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: 02/13/2024
• 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
• Patient Age: 65 YR
• Patient Sex: Female