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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 TECT1612AR
Device Problems Degraded (1153); Migration or Expulsion of Device (1395); Product Quality Problem (1506); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Abdominal Pain (1685); Abscess (1690); Arthritis (1723); Bruise/Contusion (1754); Purulent Discharge (1812); Edema (1820); Emotional Changes (1831); Foreign Body Reaction (1868); Bone Fracture(s) (1870); Hematoma (1884); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Scar Tissue (2060); Sepsis (2067); Hernia (2240); Distress (2329); Discomfort (2330); Injury (2348); Joint Dislocation (2374); Ascites (2596); No Code Available (3191); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of hernia. It was reported that after an inguinal laparoscopic herniorrhaphy procedure where this device was implanted, the patient experienced abdominal pain, infection, secretion/build-up of infectious pus in the pelvic region, tenderness, abscess, sepsis, dislocation of hip, and general injury as well as emotional distress. The product was alleged to have become disintegrated and misshapen. Treatment included a pain control regimen as well as medical intervention.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of hernia. It was reported that after an inguinal laparoscopic herniorrhaphy procedure where this device was implanted, the patient experienced abdominal pain, infection, secretion/build-up of infectious pus in the pelvic region, tenderness, abscess, sepsis, dislocation of hip, discomfort to umbilical area, bruising, right leg/hip/groin/knee pain, and general injury as well as emotional distress. The product was alleged to have become disintegrated and misshapen. Treatment included a pain control regimen as well as medical intervention.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of inguinal hernia. It was reported that after an inguinal laparoscopic herniorrhaphy procedure where this device was implanted, the patient experienced abdominal pain, infection, secretion/build-up of infectious pus in the pelvic region, tenderness, abscess, sepsis, dislocation of hip, discomfort to umbilical area, bruising, right leg/hip/groin/knee pain, and general injury as well as emotional distress. The product was alleged to have become disintegrated and misshapen. Treatment included a pain control regimen as well as medical intervention. Relevant tests/laboratory data: on (b)(6) 2016: mri of lower extremity for right hip pain showed significant degenerative changes, findings compatible with subchondral fracture and suspected avascular necrosis of right femoral head, band of bone marrow edema to right femoral neck which may represent stress response, and marked edematous changes as well as hemorrhagic changes involving numerous muscle groups about the right hip and proximal right thigh.
 
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Brand NamePARIETEX
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, CT 06473
2034925563
MDR Report Key7639899
MDR Text Key112408706
Report Number9615742-2018-01370
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K982532
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 05/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTECT1612AR
Device Catalogue NumberTECT1612AR
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 Received04/21/2021
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: 06/26/2018 Patient Sequence Number: 1
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