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U.S. Department of Health and Human Services

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

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COVIDIEN PARIETEX PROGRIP HERNIA MESH 4.7IN X 3IN; MESH, SURGICAL, POLYMERIC Back to Search Results
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.
 
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Brand Name
PARIETEX PROGRIP HERNIA MESH 4.7IN X 3IN
Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
COVIDIEN
MDR Report Key7591143
MDR Text Key110909759
Report NumberMW5077773
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 NumberTEM1208GL
Device Lot NumberSKF00386
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/11/2018
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Age34 YR
Patient Weight84
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