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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN COVIDIEN PARIETEX PROGRIP HERNIA MESH

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COVIDIEN COVIDIEN PARIETEX PROGRIP HERNIA MESH Back to Search Results
Lot Number SK700377
Event Date 07/13/2011
Event Type  Injury  
Event Description

Pt called to report adverse reactions to covidien paritex progrip, which he had implanted on (b)(6) 2011, due to an inguinal hernia. Pt stated since implantation of the parietex progrip mesh, he experiences constant pain in his right testicle. He also stated he has severe pain starting in his right groin up to his belly button. He also experiences pain down the inside of his leg to the bottom of his foot. Pt also says he often feels an "electrical jolt" feeling between his testicle and leg, on the back of his knee, and where the pain ends up through his groin. He stated his lower abdominal area is also in constant pain and has spasms. Pt says he received no warning from his doctor or surgeon of possible adverse reactions or side effects, he was only told there is a 2% chance of reoccurrence. His everyday living has been severely impaired and he says he is basically disabled due to constant pain. Pt is concerned the mesh is possibly poisoning him since it's made of polyester. He said he used to do auto body work and painted cars for 13 yrs, and was very used to things with "poly" in them. Now, he claims the smell of anything with "poly" in it makes him sick. He stated he takes pain medication, but it doesn't really help. He says his sleep is disrupted, he sleeps very little due to pain, and the little amount of sleep causes some anxiety for him. He said he had the mesh implanted at (b)(6).

 
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Brand NameCOVIDIEN PARIETEX PROGRIP
Type of DeviceHERNIA MESH
Manufacturer (Section D)
COVIDIEN
MDR Report Key2943724
Report NumberMW5028819
Device Sequence Number1
Product CodeFTL
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/04/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/04/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Service Personnel
Device LOT NumberSK700377
Is The Reporter A Health Professional? No

Patient TREATMENT DATA
Date Received: 02/04/2013 Patient Sequence Number: 1
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