MAUDE Adverse Event Report: COVIDIEN PARIETEX PROGRIP HERNIA MESH 4.7IN X 3IN; MESH, SURGICAL, POLYMERIC

Catalog Number TEM1208GL

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

Patient Problems Abscess (1690); Unspecified Infection (1930); Pain (1994); Staphylococcus Aureus (2058); Anxiety (2328); Depression (2361)

Event Date 05/13/2011

Event Type  Injury  

Event Description

Pt experienced pain and issues after hernia mesh implant.Issues increased in 2016 where he was diagnosed with a staph infection and abscesses on his left groin.Reoccurring abscesses had to be surgically drained and drs found a rare form of staphylococcus lugdunensis.His pain persisted which led to having the mesh implant removed.While removing the mesh, the surgeon noticed the pt's iliohypogastric and ilioinguinal nerves were missing / severed from his previous surgery.Pt also complains of sexual dysfunction, pain with erection and ejaculation, and can no longer have sex with partner.The pt has also been diagnosed with anxiety, depression, ptsd and bacterial overgrowth.His medical bills have skyrocketed and drs have turned him away due to the complexity of the case.Drs have also refused to accept his workers compensation.The pt's employer has now retaliated due to him constantly requesting accommodation.

• Brand Name: PARIETEX PROGRIP HERNIA MESH 4.7IN X 3IN
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 7591143
• MDR Text Key: 110909759
• Report Number: MW5077773
• Device Sequence Number: 1
• Product Code: FTL
• 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: 06/11/2018

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: No Information
• Device Catalogue Number: TEM1208GL
• Device Lot Number: SKF00386
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/11/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 84