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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PARIETEX MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION SAS PARIETEX MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number TECR1510
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/16/2013
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

According to the reporter: the patient underwent a laparoscopic hernia procedure for an inguinal hernia. The surgeon repaired both sides, right and left, with mesh. Since the surgery the patient had been experiencing sharp pains and uncomfortable feelings in the pelvic, hip, and groin area. The right side was so bad that the patient had not been able to lift their leg to get in the car. The patient was no able to bend all the way down to tie their shoes. The patient was unable to lift their leg without the aid of their hands to pull it up. Last year, the symptoms had worsened on the left side. The patient said the left side "felt like a brillo pad was breaking up into pieces under the surface of my skin. " there were 4-5 noticeable uncomfortable lumps under the skin. The patient could not put on pants or underwear without being in pain. The patient stated it was depressing. The patient was not able to have sex for months even before the bulge got bigger and still to this present day. After about another month the lumps turned into one big bulge extending from the hip area and the other in the groin area. After about another month the bulge turned purple, red, and black. The patient went to the emergency room and a cat scan was done. They saw scar tissue. The bulge was leaking in two different areas, one in the hip and one in the groin. The patient was prescribed antibiotics and pain medicine for about a month. The patient was referred by their primary care doctor to a surgeon to have things looked at and possibly remove the mesh. The patient had a surgery scheduled and had been in excruciating pain for the past 6 months. The patient's performance at work had slowed down noticeable. It was depressing taking all the pain medication that did not seem to work. Tramadol has bot been that good for the patient. The patient cannot work with a wound vac on or do every day activities. The patient cannot play with their kids like they used to. The patient can barely tie their own shoes because of the infected mesh. The patient was unable to stand for periods at a time without sharp pains shooting down from the hip to the leg making the legs give out unless the patient were to sit down. The patient had to go to the emergency room because the bulge was so big and painful and uncomfortable. It was still draining out of two different areas the patient had to keep changing bandages at the very least twice a day because of the leakage. The patient was hospitalized in 2013 for intestinal blockage due to the hernia mesh.

 
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
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Brand NamePARIETEX
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FRANCE 01600
Manufacturer (Section G)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FRANCE 01600
Manufacturer Contact
sharon murphy
60 middletown avenue
north haven , CT 06473
2034925267
MDR Report Key6471436
Report Number9615742-2017-05072
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type OTHER
Reporter Occupation Other
Type of Report Initial
Report Date 03/13/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/07/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date10/31/2017
Device MODEL NumberTECR1510
Device Catalogue NumberTECR1510
Device LOT NumberSMJ00794
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/13/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured11/12/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/07/2017 Patient Sequence Number: 1
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