MAUDE Adverse Event Report: ETHICON INC. PROCEED MESH MESH, SURGICAL, POLYMERIC

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Adhesion(s) (1695)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4). Device not returned.    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: weight, bmi at the time of index procedure date of initial surgical procedure. What were current symptoms following the index surgical procedure? onset date? what are the patient comorbidities/concomitant medications? what was surgical approach (open, laparoscopic or other)? any concurrent surgeries or procedures? were pre-existing adhesions noted during the procedure? location and severity of adhesions? please provide details of surgical intervention for adhesion. What is the relationship of adhesion to device implanted? 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 an umbilical hernia procedure on an unknown date in 2014 and the mesh was implanted. The patient returned in 2021 for a another surgery and found that the device had a hole in the middle of the mesh. The patient had adhesions taken down and a competitor's mesh was placed over the hole in the existing hernia mesh. The procedure and patient outcome is unknown.

• Brand Name: PROCEED MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• Manufacturer (Section G): ETHICON INC.-CORNELIA; 655 ethicon circle; cornelia GA 30531
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08876 ; 9082182213
• MDR Report Key: 11579928
• MDR Text Key: 243916613
• Report Number: 2210968-2021-02817
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K060713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/20/2021
• 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?

• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/27/2021 Patient Sequence Number: 1