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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PROGRIP ; HERNIA MESH
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MEDTRONIC PROGRIP ; HERNIA MESH Back to Search Results
Lot Number
Device Problems Break (1069); Material Erosion (1214); Migration or Expulsion of Device (1395)
Patient Problems Autoimmune Disorder (1732); Emotional Changes (1831); Muscle Weakness (1967); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Shock (2072); Tissue Damage (2104); Toxicity (2333); Injury (2348); Depression (2361); Disability (2371); Ambulation Difficulties (2544); No Information (3190); No Information (3190)
Event Date 09/25/2015
Event Type  Injury  
Event Description
Reporter said he had mesh implant which broke and eroded into his appendix, scrotum, belly and into his bottom.
 
Event Description
Additional information received from reporter on 05/11/2017 for report #mw5063263.Reporter called to change his phone number.
 
Event Description
Additional information received from reporter for report #: mw5063263.Reporter states an additional piece of mesh was implanted during his hernia surgery in 2015 without his knowledge and that all of the mesh devices that were implanted were recalled prior to him having surgery.Reporter states he has had recurrent infections, nerve damage, organ damage, pig prosthetic tissue implant, bowel damage, bladder damage, pain and an abundance of scar tissue and adhesions due to the mesh.He also states that he wants to have the mesh removed and doctors have told him it's not possible, if removed there would be more damage to his organs.Reporter has stated feeling depressed and has suicidal thoughts several times a day.He states that he does not have a plan to harm himself but feels like life is not worth living anymore.Reporter stated that he has stopped taking his antidepressants last year because they do not work and is no longer being treated by a doctor for his mental health issues.
 
Event Description
Additional information received from reporter for report #mw5063263 on 01/03/2018.Reporter states that some time in 2016, he filed a complaint via phone in relation to his three hernia meshes.He says he accidentally reported all three mesh types instead of just two; (3d max by bard and progrip by medtronic).Reporter is requesting that fda rectify this error by taking out the pigskin mesh by xenmatrix that was accidentally included.According to reporter, during his initial complaint, he was of the impression that the three types of mesh were of same material but came to find out that they were actually not.For as report states, the 3d max and progrip are made of polypropylene while the pigskin is pretty much natural.Reporter's address has also changed.
 
Event Description
Additional information received on 07/13/2016 for report mw5063263.Patient called to add additional information to report he phoned in a week ago.Patient stated he wanted to report on the second mesh that was implanted in him since he reported on the first mesh last week.Patient had a mesh revision after his body rejected the 3dmax mesh initially implanted.Patient stated the revision took place on (b)(6) 2015, where he was implanted with the xenmatrix mesh and the 3dmax mesh was completely removed.Patient said his body rejected the xenmatrix mesh as well.He said the mesh migrated throughout his body, into his anus, penis, scrotum, stomach and bowels.Patient said he is now completely bedridden and suffers from extreme pain, nerve damage, nerve entrapment, pelvic floor dysfunction, shock, toxic issues, neuroma in pelvis, bladder and bowel issues, autoimmune disease and muscle issues.Patient stated the revision with xenmatrix mesh has become a "living nightmare" for him as he no longer has a job or income and lost his apartment.Patient said he was told by the implanting doctor that the xenmatrix mesh was going to dissolve within 6 months, but that is not what happened.Patient said instead of dissolving, the mesh adhered and spread throughout his body causing him painful, disabling, permanent problems.Patient is desperate for help and/or any kind of relief.
 
Event Description
Reporter said he had mesh implant which broke and eroded into his appendix, scrotum, belly and into his bottom.
 
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Brand Name
PROGRIP
Type of Device
HERNIA MESH
Manufacturer (Section D)
MEDTRONIC
MDR Report Key5774864
MDR Text Key49048082
Report NumberMW5063263
Device Sequence Number3
Product Code KDD
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,Followup,Followup,Followup,Followup
Report Date 01/03/2018
3 Devices were Involved in the Event: 1   2   3  
2 Patient was Involved in the Event
Date FDA Received07/05/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Lot Number
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Type of Device Usage N
Patient Sequence Number0
Patient Weight58
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