MAUDE Adverse Event Report: ETHICON INC. GYNECARE MESH UNKNOWN; MESH, SURGICAL

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

Patient Problem Incontinence (1928)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Attempts are being 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.The patient demographic info: age, weight, bmi at the time of index procedure, name of initial surgical procedure? the diagnosis and indication for the initial surgical procedure? what were current symptoms following the index surgical procedure? onset date? what are the patient comorbidities/ concomitant medications? product code(s) and lot #¿s were any concomitant procedures performed? onset date/time of the pain from surgery? location and character of the pain? what medical intervention was given for the pain management? results? has incontinence changed from pre-surgery condition? is incontinence worse, better, or returned to the same? please provide surgical findings of the reoperations.Does the surgeon believe that the ethicon product (tvt) involved caused and/or contributed to the hernia? what is physician¿s opinion as to the etiology of or contributing factors to these events? what is the patient's current status? event related to tvt device on (b)(6) 2000 reported via mw # 2210968-2021-03618, event related to tvt device on (b)(6) 2001 reported via mw # 2210968-2021-03619.

Event Description

It was reported that a patient underwent a sling procedure on (b)(6) 2002 and the mesh was implanted.It was reported that the patient had stress incontinence.It was also reported that the patient had a right inguinal hernia in 2008.It was reported that the patient removed a portion of the mesh in (b)(6) 2017.Additional information was requested.

• Brand Name: GYNECARE MESH UNKNOWN
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 11705008
• MDR Text Key: 261316623
• Report Number: 2210968-2021-03620
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/23/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/23/2021
• Initial Date FDA Received: 04/22/2021
• 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