MAUDE Adverse Event Report: ETHICON INC. ULTRAPRO MESH UNKNOWN PRODUCT; MESH, SURGICAL, POLYMERIC

Device Problem Migration (4003)

Patient Problems Cyst(s) (1800); Foreign Body Reaction (1868); Unspecified Infection (1930)

Event Date 12/14/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 4/1/2021.(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.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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that a patient underwent a laparoscopic inguinal hernia repair on an unknown date in 2015 and the mesh was implanted.It was reported that the patient experienced a rare rejection of the mesh.It was reported that on (b)(6) 2020 a cyst found at the mesh site was drained laparoscopically.The patient's follow up presented with the cyst refilled and mesh floating inside.The surgeon advised to remove cyst and mesh with revision.It was also reported that the patient had infection and that the doctor advised to remove cyst and mesh to determine the type of infection.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 4/29/2021.Additional information was requested and the following was obtained: 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.I'm sorry slow in response.I believe i stated as soon as i find surgeon with experience correcting issue i'll gladly share with you my complete medical history.I thought i also mentioned i don't believe i lodged complaint rather i wrote looking for advice on your product's failure in my now 6 year old inguinal hernia repair perform at (b)(6).So many possible causes, without experienced surgeon our chance to understand what did happened is diminished imo.I'm surprised it's not in both our best interest whom does revision.What should we look for in determining cause.Trust i want to be well, it's been so many years, taking a little extra time seems reasonable.Maybe we never will know but i don't want to live with , 'we didn't try' this rare event should/could be used to advance science not as a one off procedure for surgeon who's never done one.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.Product complaint # (b)(4).Date sent to the fda: 4/29/2021.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.

• Brand Name: ULTRAPRO MESH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11606601
• MDR Text Key: 254875738
• Report Number: 2210968-2021-02969
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K033337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 03/03/2021

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/03/2021
• Initial Date FDA Received: 04/01/2021
• Supplement Dates Manufacturer Received: 04/07/2021
• Supplement Dates FDA Received: 04/29/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention