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

Device Problem Migration (4003)

Patient Problems Erosion (1750); Calcium Deposits/Calcification (1758)

Event Date 01/01/2021

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, date and 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? the initial approach for the index surgical procedure? any concurrent procedure/ device implantation? were there any intra-operative complications? when was the mesh extrusion first noted by a physician? mesh extrusion symptoms and diagnostic confirmation? describe any medical/ surgical intervention for extrusion including dates and surgical findings.Product code and lot #? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status?.

Event Description

It was reported that a patient underwent a gynecological procedure on an unknown date in 2021 and the mesh was implanted.It was reported that the tape extruded into bladder with stone formation and bladder symptoms.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: 11705428
• MDR Text Key: 247981435
• Report Number: 2210968-2021-03629
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/23/2021
• 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