MAUDE Adverse Event Report: ETHICON INC. PHYSIOMESH OVAL 15X20; MESH, SURGICAL

Model Number PHY1520V

Device Problem Shelf Life Exceeded (1567)

Patient Problems Unspecified Infection (1930); Scar Tissue (2060); Obstruction/Occlusion (2422)

Event Date 10/22/2010

Event Type  Injury  

Event Description

On (b)(6) 2010 had a 15x20 oval piece of physiomesh put over an aortobifemoral bypass incisional hernia that measured 2.5 cm, didn't last two weeks.On (b)(6) 2010 had mesh removed as well as abdominal muscles, nerves, and belly button.No pathology report because "dr knew what organism was cause of infection" even though the hospital and insurance companies want everything to go to pathology.Nothing ever happened to surgeon or hospital.Physiomesh was recalled 05/2015 and taken off market 12/2015 after i went thru a bowel obstruction from scar tissue from 2 prior surgeries.

• Brand Name: PHYSIOMESH OVAL 15X20
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): ETHICON INC. ; NJ
• MDR Report Key: 7502208
• MDR Text Key: 108149363
• Report Number: MW5077106
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• 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: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/01/2011
• Device Model Number: PHY1520V
• Device Lot Number: CH9HMJZO
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 46 YR
• Patient Weight: 64