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

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

Patient Problems Autoimmune Disorder (1732); Incontinence (1928); Pain (1994); Unspecified Kidney or Urinary Problem (4503); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 01/31/2016

Event Type  Injury  

Event Description

It was reported that a patient underwent a sling procedure on (b)(6) 2016 and mesh was implanted.The patient reported that the mesh causes pain in the upper legs, groin and vagina, the patient had difficulty when moving as it would cause pain.The patient was told this would eventually ease over time.The patient also became more incontinent and needed to urinate often and could only partially empty the bladder, the patient was told to rock back and forth on the toilet each time to empty the bladder fully before standing so they wouldn't leak when getting up to stand.The patient is having surgery on an undisclosed date, to potentially remove some of the mesh as it is almost close to erosion of the vaginal cavity.The patient has been instructed to use a cream to insert vaginally to thicken the area to help stop erosion.The patient further reported having muscle spasms in the legs, developing fibromyalgia, sjogren's disease and consist pain from the waist down.No further information is available as reporter details have not been disclosed (confidential).

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.

• 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: 18924278
• MDR Text Key: 337907990
• Report Number: 2210968-2024-03139
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 03/18/2024
• 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: 03/13/2024
• 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