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 Abdominal Pain (1685); Pain (1994); Scar Tissue (2060); Hernia (2240); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/10/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.

Event Description

It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2013 and mesh was implanted.It was reported that the patient underwent hernia repair surgery on (b)(6) 2014 and mesh was implanted.It was reported that the patient experienced pain and infection.On (b)(6) 2013 ultrasound on the abdominal wall detected: "palpatory swelling in the right paraumbilical site, the presence of liquid collection of 5 cm positioned above the prosthetic mesh used is detected in the reduction of the spinal cord and in the vicinity of the surgical scar."on (b)(6) 2014 was hospitalized with urgency due to a several abdominal pain and was hospitalized there until (b)(6) 2014 with the following diagnosis: " abdominal wall prosthesis implant infection".No additional information provided.

Manufacturer Narrative

Date sent to the fda: 8/19/2021.Additional b5 narrative: it was reported that the patient experienced pain.

Manufacturer Narrative

Date sent to the fda: 08/31/2021.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Brand Name: PROLENE MESH 15X15CM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12336199
• MDR Text Key: 267053929
• Report Number: 2210968-2021-07439
• 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: foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Catalogue Number: PMM3
• Device Lot Number: DKB561
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention