MAUDE Adverse Event Report: JOHNSON & JOHNSON / ETHICON, INC. PROLENE MESH II - 3X6 INCHES; MESH, SURGICAL, POLYMERIC

Model Number PMII

Device Problems Material Fragmentation (1261); Defective Device (2588)

Patient Problems Abdominal Pain (1685); Foreign Body Reaction (1868); Unspecified Infection (1930); Inflammation (1932); Neuropathy (1983); Pain (1994); Urinary Retention (2119); Numbness (2415); Cramp(s) /Muscle Spasm(s) (4521); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/30/2014

Event Type  Injury  

Event Description

Had to have a second surgery; i had a laparoscopic left inguinal hernia repair with ethicon prolene mesh ii (pmii) on (b)(6) 2014 at (b)(6) hospital in (b)(6) performed by dr.(b)(6).Postoperatively i developed abdominal pain, groin pain, inability to empty my bladder, bladder spasms, pain with sitting, pain with standing, pain with walking, left leg numbness, left foot numbness with my foot turning white, and dyspareunia, all of which continued to get worse over time.I had surgery on (b)(6) 2019 at (b)(6) medical center by dr.(b)(6) to remove the mesh which had fragmented into pieces and entrapped blood vessels and nerves, the removal of a folded meshoma with entrapment neuropathy and infection, removal of the mesh which had adhered to my bladder, abdominal wall and other structures, and the repair of a recurrent left inguinal hernia.The ethicon prolene mesh ii is composed of polypropylene, the same composition as the ethicon physiomesh which was recalled.Prolene mesh ii is a defective and dangerous product and should be taken off the market.Excision of mesh from left abdomen: fibroadipose tissue with foreign body reaction and chronic inflammation, mesh as per gross description.Excision of left genital nerve.Excision of left ilioinguinal nerve.Excision of left ileo hypogastric nerve."left side old mesh" is a 11.5 x 4.5 x 0.2 cm pink-tan, irregular, soft tissue with cautery artifact and clear synthetic mesh.Attached is a 3.2 x 2.2 x 0.8 cm yellow-tan, lobulated fibrofatty soft tissue.Sectioning reveals a pink-tan, smooth cut surface with synthetic embedded mesh.Sectioning the fat reveals a yellow homogenous and glistening cut surface.A gross photograph is taken.Fda safety report id# (b)(4).

• Brand Name: PROLENE MESH II - 3X6 INCHES
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): JOHNSON & JOHNSON / ETHICON, INC.
• MDR Report Key: 12615558
• MDR Text Key: 276347631
• Report Number: MW5104514
• Device Sequence Number: 1
• Product Code: FTL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2019
• Device Model Number: PMII
• Device Lot Number: HCE545
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 25 YR
• Patient Weight: 50