• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SOFRADIM PRODUCTION SAS PARIETEX MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number TECR1510
Device Problems Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Erosion (1750); Emotional Changes (1831); Fistula (1862); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Nerve Damage (1979); Internal Organ Perforation (1987); Pain (1994); Scar Tissue (2060); Hernia (2240); Distress (2329); Injury (2348); Deformity/ Disfigurement (2360); Obstruction/Occlusion (2422); Blood Loss (2597); Abdominal Distention (2601); No Code Available (3191); Dyspareunia (4505); Unspecified Tissue Injury (4559)
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 resulting in an unspecified adverse outcome. Product was used for therapeutic treatment. Preoperative and postoperative diagnosis was ventral hernia. The procedure performed was repair of ventral hernia including small bowel resection. The patient had experienced pain, adhesions, bowel obstruction, reherniation, and bowel resection. (b)(6) 2005- the patient underwent a subsequent procedure for total abdominal hysterectomy/bilateral salpingo-oophorectomy, abdominal hernia repair and small bowel resection. The pre-op diagnosis was fibroid uterus, complex endometrial hyperplasia and abdominal wall hernia. The post-op diagnosis was fibroid uterus, complex endometrial hyperplasia, abdominal wall hernia, dense omental/bowel adhesions to the anterior abdominal wall. (b)(6) 2009 - the patient underwent a procedure for laparoscopy converted to laparotomy and removal of the skin and sac and lysis of adhesions and resection of small bowel segment with anastomosis an enterotomy for decompression of severely distended small bowel. Irrigation of the abdominal cavity with antibiotic solution. The pre-op diagnosis was small bowel obstruction and a large umbilical hernia and post-op diagnosis was small bowel obstruction secondary to extremely tight adhesions to previous mesh that the patient has from previous repair. Also, massive adhesions and a large umbilical hernia. The patient had experienced pain, adhesions, bowel obstruction, reherniation, bowel resection.
 
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 of a ventral hernia. It was reported that after implant, the patient experienced mental/physical pain, abdominal pain, injury, deformity, mesh erosion, mesh contraction, infection, fistula, inflammation, scar tissue, organ perforation, dyspareunia, blood loss, nerve damage, adhesion of the mesh to small bowel causing obstruction, and recurrence. Post-operative patient treatment included pain control medications, mesh removal, repair of ventral hernia with implant of new mesh, lysis of adhesions, and resection of bowel.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7322789
MDR Text Key101834426
Report Number9615742-2018-00453
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 Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 07/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTECR1510
Device Catalogue NumberTECR1510
Device Lot NumberSFG00482
Was Device Available for Evaluation? No
Date Manufacturer Received07/13/2022
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: 03/08/2018 Patient Sequence Number: 1
-
-