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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 TEC1510
Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001); Material Split, Cut or Torn (4008)
Patient Problems Abdominal Pain (1685); Emotional Changes (1831); Hemorrhage/Bleeding (1888); Failure of Implant (1924); Unspecified Infection (1930); Pain (1994); Deformity/ Disfigurement (2360); Bowel Perforation (2668); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Death  
Manufacturer Narrative

Concomitant product: tec1510 parietex std py 15x10cm x1 (lot # sjj00225). (b)(4). 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 right and left inguinal hernia repair. It was reported that after implant, the patient experienced abdominal pain, rectal bleeding, diverticulitis, mesh broken into pieces, pieces migrated, failure of mesh, injury, bowel perforation, infection, pain, emotional pain, harm, disability, disfigurement, mental anguish, and death. Post-operative patient treatment included revision surgery, removal of pieces of mesh, antibiotics, and hospitalizations. Information received indicates the patient is now deceased, due to infection from the hernia mesh.

 
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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
tracy landers
5920 longbow drive
boulder, CO 80301
3035816943
MDR Report Key12219709
MDR Text Key263214633
Report Number9615742-2021-01809
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK982532
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/09/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/23/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberTEC1510
Device Catalogue NumberTEC1510
Device LOT NumberSJJ00225
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/21/2021
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: 07/23/2021 Patient Sequence Number: 1
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