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

Catalog Number PROMESHUNK

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

Patient Problems Edema (1820); Pain (1994)

Event Date 02/28/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Adverse events will submitted via mw# 2210968-2020-04485, and mw# 2210968-2020-04486.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.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 the operative report? does ethicon have your husband's permission to contact the surgeon, in the event ethicon would like to contact your husband's surgeon for more clinical information to be used for a product quality complaint investigation?.

Event Description

It was reported that a patient underwent and inguinal hernia repair surgery on an unknown date in (b)(6) 2020.It was reported that the patient had extreme pain in groin area since surgery.It was reported that the products used were prolene mesh and op report mentions unknown vicryl and unknown prolene sutures.It was also reported that the patient is on heavy pain medication and has seen urologist, surgeon, and cardiologist.It was reported that the patient is going to see a hernia repair specialist on (b)(6) 2020.

Manufacturer Narrative

Product complaint # (b)(4) date sent to the fda: 07/15/2020 corrected information: b3 additional information: d6, h6 - patient codes additional information was requested and the following was obtained: if in your possession, may we have a copy of the operative report? does ethicon have your husband's permission to contact the surgeon, in the event ethicon would like to contact your husband's surgeon for more clinical information to be used for a product quality complaint investigation? i am currently busy taking care of my husband who is now on his fifth month of excruciating groin pain after bi-lateral open hernia repair and the prolene products were put in his body, which i was not told by the surgeon, chris anderse, summitt surgical group at wellstar regional hospital in marietta, ga.The surgery was on (b)(6), 2020.The surgeon and the hospital will not give me lot numbers for the products, which the fda tells me that i need to know.They claim they do not record the lot numbers.The surgeon maintains that all is fine with the surgery.I have requested and been denied a ct scan of the abdomen and the surgical sites by the surgeon and the hospital.I now know that he has edema around the mesh in his body fro m a recent ct scan done by another healthcare system, not wellstar.This scan was done yesterday, (b)(6) 2020 in the er room of a (b)(6) hospital.The bottom line is not everything is fine for my husband.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, 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: PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10139361
• MDR Text Key: 194681059
• Report Number: 2210968-2020-04484
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PROMESHUNK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/07/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR