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

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.

• Brand Name: UNKNOWN PARIETEX PRODUCT
• Type of Device: MESH, 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 Key: 10747478
• MDR Text Key: 213420391
• Report Number: 9615742-2020-02411
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PARIETEX PRODUCT
• Device Catalogue Number: UNKNOWN PARIETEX PRODUCT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/11/2020
• Initial Date FDA Received: 10/28/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other