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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
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.

 
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Brand NamePROGRIP
Type of DeviceHERNIA MESH
Manufacturer (Section D)
MEDTRONIC
MDR Report Key5774864
Report NumberMW5063263
Device Sequence Number3
Product CodeKDD
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Followup,Followup,Followup
Report Date 01/03/2018
2 DeviceS WERE Involved in the Event: 1   2  
0 PatientS WERE 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
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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