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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS UNKNOWN PARIETEX PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UNKNOWN PARIETEX PRODUCT
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Autoimmune Disorder (1732); Extreme Exhaustion (1843); Fatigue (1849); Neuropathy (1983); Pain (1994); Abnormal Vaginal Discharge (2123); Ulcer (2274); Injury (2348); Constipation (3274)
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

According to the reporter, following a laparoscopic ventral mesh rectopexy, the patient had bowel prolapses, and the patient¿s health has declined. It was stated that the patient suffered with severe constipation and had to take several medicines every day for bowels including weekly dose of picolax. The patient had autoimmune issues including fibromyalgia, pelvic, rectal and vaginal pain. The patient had issues with stomach, migraines, joint pains, neuropathy and excruciating burning on the legs and feet. Iv also developed lichen planus vaginally and rectally that the patient had to see a skin specialist. It was stated that the patient¿s health has deteriorated massively, fatigue, exhaustion, pain and sickly metallic smelling stools and, discharge and body odor. The patient also had mouth ulcers and masses of hair loss since the mesh implant. The patient incurred a permanent injury.

 
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Brand NameUNKNOWN PARIETEX PRODUCT
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR 01600
Manufacturer (Section G)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR 01600
Manufacturer Contact
lisa hernandez
60 middletown ave
north haven, CT 06473
2034925563
MDR Report Key10747478
MDR Text Key213420391
Report Number9615742-2020-02411
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 10/28/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/28/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberUNKNOWN PARIETEX PRODUCT
Device Catalogue NumberUNKNOWN PARIETEX PRODUCT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/11/2020
Was Device Evaluated By Manufacturer? No Answer Provided
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: 10/28/2020 Patient Sequence Number: 1
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