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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 TECT1510ADP2R
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fatigue (1849); Fever (1858); Pain (1994); Injury (2348); No Code Available (3191)
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. It was reported that after a procedure where this device was implanted, the patient experienced an unspecified adverse outcome.
 
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. It was reported that after a hernia procedure where this device was implanted, the patient experienced mildly enlarged mesenteric lymph node, aches, pains, random bouts of fever, high blood pressure (for the first time in his life), an unexplained nerve/burning pains in his testicles and groin, and a sharply diminished libido. Plaintiff has, since early 2018, lost 10-15 pounds for no apparent reason and has a decreased appetite. Plaintiff has also experienced back pain and fatigue. After the original procedure, additional potentially related procedures were performed, including revision.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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. It was reported that after a right inguinal hernia repair procedure where this device was implanted, the patient experienced mildly enlarged mesenteric/periaortic/iliac lymph nodes,aches, pains, random bouts of fever, high blood pressure (for the first time in his life), burning pains in his testicles/groin, and a sharply diminished libido. Plaintiff has, since early 2018, lost 10-15 pounds and has a decreased appetite. Plaintiff has also experienced back pain and fatigue. After the original procedure, additional potentially related procedures were performed, including revision.
 
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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 06473
2034925563
MDR Report Key7511836
MDR Text Key108179082
Report Number9615742-2018-01136
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 10/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2018
Device Model NumberTECT1510ADP2R
Device Catalogue NumberTECT1510ADP2R
Device Lot NumberSNJ0071X
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 Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/15/2013
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: 05/14/2018 Patient Sequence Number: 1
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