MAUDE Adverse Event Report: ETHICON INC. TVT DEVICE LCM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number 830041BL

Device Problem Migration (4003)

Patient Problems Erosion (1750); Hemorrhage/Bleeding (1888); Incontinence (1928); Pain (1994); Scar Tissue (2060); Ambulation Difficulties (2544); Unspecified Tissue Injury (4559)

Event Date 02/02/2007

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Component code: (b)(4) device not returned.Attempts have been 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.If in your possession, may we have a copy of your operative report? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? if so, please provide your surgeon¿s name, contact information and sign release of medical information form attached.Events associated with patient's first event reported via mw #2210968-2021-08854.Events associated with patient's second event reported via mw #2210968-2021-08855.Events associated with patient's third event reported via mw #2210968-2021-08856.Events associated with patient's fourth event reported via mw #2210968-2021-08857.

Event Description

It was reported that the patient underwent a gynecological procedure on an unknown date and the mesh was implanted.It was reported that the device eroded through the vaginal wall causing pain, bleeding, and further prolapse scarring.It was reported that the patient had an operation to recover the exposed mesh and a autologous sling put in.It was also reported that the patient has never recovered and is now double incontinent with two bowel prolapses, a bladder prolapse, and a rectal prolapse.It was also reported that the patient is waiting to find if a stoma is required for the remainder of life.It was also reported that the patient is disabled and destroyed because of misuse of the device.It was also reported that the patient is unable to walk far, is in constant pain, and has cutting, bleeding, and sharp, stabbing pain in the vagina and back passage.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: (b)(6) 2021.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, 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.Additional information: lot 30271137, provided was determined as an invalid lot number in the system database.Therefore, no dhr review can be performed.

• Brand Name: TVT DEVICE LCM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; 20 puits-godet; neuchatel 2000 ; SZ 2000
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12530263
• MDR Text Key: 273767825
• Report Number: 2210968-2021-08854
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K012628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/23/2021

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
• Device Catalogue Number: 830041BL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/25/2021
• Initial Date FDA Received: 09/24/2021
• Supplement Dates Manufacturer Received: 11/17/2021
• Supplement Dates FDA Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female