MAUDE Adverse Event Report: ETHICON INC. MALLA PROLENE SMALL 6CM X 11CM; MESH, SURGICAL, POLYMERIC

Catalog Number PMS3

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

Patient Problems Erythema (1840); Inflammation (1932)

Event Date 10/10/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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.Patient symptoms manifestations (location, severity, appearance, systemic or local reaction).Date - time of onset of infection from the surgical procedure? 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? results? what is meant by "stopped using the device?" was the mesh removed by surgical intervention?.

Event Description

It was reported that a patient underwent a right oblique inguinal hernia on an unknown date and the mesh was implanted.It was reported that there was post-op inflammation.It was reported that the patient suffered from erythema, inflammation on the skin at which the product was implanted after sewing.It was also reported that using the device stopped and the patient was given treatment of anti-infection and anti-allergy.Then the patient's condition changed better.

Manufacturer Narrative

Date sent to the fda: 01/07/2020.Additional information: h4.A manufacturing record evaluation was performed for the finished device batch and no non-conformances were identified.Additional information was requested, and the following was obtained: all answers are unobtainable patient symptoms manifestations (location, severity, appearance, systemic or local reaction) date - time of onset of infection from the surgical procedure? 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? results? what is meant by "stopped using the device?" was the mesh removed by surgical intervention?.

• Brand Name: MALLA PROLENE SMALL 6CM X 11CM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9356121
• MDR Text Key: 167548323
• Report Number: 2210968-2019-90184
• 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: 11/12/2019

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 Expiration Date: 05/31/2023
• Device Catalogue Number: PMS3
• Device Lot Number: MGQ143
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/12/2019
• Initial Date FDA Received: 11/21/2019
• Supplement Dates Manufacturer Received: 12/12/2019
• Supplement Dates FDA Received: 01/07/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention