MAUDE Adverse Event Report: ETHICON INC. PROLENE MESH 15X15CM; MESH, SURGICAL, POLYMERIC

Catalog Number PMM3

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

Patient Problems Erythema (1840); Inflammation (1932); Pain (1994)

Event Date 01/17/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint #pc (b)(4).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.The patient demographic info: weight, bmi at the time of index procedure other relevant patient history/concomitant medications what is physician¿s opinion as to the etiology of or contributing factors to this event were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? were cultures performed? results? what medical intervention was performed for the infection? results? were any concomitant procedures performed? onset date/time of the pain from surgery location and character of the pain? is there any specific activity that precipitated the pain or eased the pain? what medical intervention was given for the pain management? results? what is the patient's current status? 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 left indirect inguinal hernia repair on (b)(6) 2020 and the mesh was implanted.It was reported that the patient suffered from erythema, inflammation and pain 3 days after using the product in the surgery.Dressing change was given to the patient regularly.About 10 days later, the patient's wound gradually improved and was discharged from the hospital.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 1/4/2021.The lot jjp074 is not valid; therefore, the manufacturing record evaluation could not be completed.Additional information was requested and the following was obtained: 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---------unobtainable other relevant patient history/concomitant medications----unobtainable what is physician¿s opinion as to the etiology of or contributing factors to this event----unobtainable were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? unobtainable.Did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? unobtainable.Were cultures performed? results? unobtainable.What medical intervention was performed for the infection? results?-unobtainable were any concomitant procedures performed? unobtainable.Onset date/time of the pain from surgery.Three days after the sewing the wound location and character of the pain? unobtainable.Is there any specific activity that precipitated the pain or eased the pain? dressing change was given.What medical intervention was given for the pain management? results? dressing change was given.About 10 days later, the patient's condition changed better.The patient was discharged from the hospital.What is the patient's current status? according to feedback, it is unobtainable for the patient's privacy.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: PROLENE MESH 15X15CM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10990510
• MDR Text Key: 220878366
• Report Number: 2210968-2020-09850
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/12/2020

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
• Device Catalogue Number: PMM3
• Device Lot Number: JJP074
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/12/2020
• Initial Date FDA Received: 12/11/2020
• Supplement Dates Manufacturer Received: 12/15/2020
• Supplement Dates FDA Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR