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

Model Number	TECT1510ADP2R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Fever (1858); Pain (1994); Injury (2348); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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.

• Brand Name: PARIETEX
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 7511836
• Report Number: 9615742-2018-01136
• Device Sequence Number: 11111674
• Product Code: FTL
• UDI-Device Identifier: 10884521180215
• UDI-Public: 10884521180215
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K982532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/05/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: TECT1510ADP2R
• Device Catalogue Number: TECT1510ADP2R
• Device Lot Number: SNJ0071X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/18/2018
• Supplement Date Received by Manufacturer: 06/20/2018; 07/27/2018; 08/08/2018; 08/08/2018
• Initial Report FDA Received Date: 05/14/2018
• Supplement Report FDA Received Date: 07/10/2018; 08/08/2018; 10/04/2018; 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention