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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCO15
Device Problems Entrapment of Device (1212); Migration or Expulsion of Device (1395); Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Erosion (1750); Hemorrhage/Bleeding (1888); Inflammation (1932); Pain (1994); Staphylococcus Aureus (2058); Seroma (2069); Hernia (2240); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Blood Loss (2597); Vascular Dissection (3160); No Code Available (3191); 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 incisional hernia x2. The procedure performed was laparoscopic incisional hernia repair. On (b)(6) 2013 - which was 2 years after the initial implantation. The patient underwent a surgical revision for repair hernia ventral with mesh. The pre-op diagnosis was incarcerated recurrent ventral hernia and post-op diagnosis incarcerated recurrent ventral hernia with 4 separate fascial defects. The patient experienced multiple surgical revisions, recurrent hernia requiring repair with placement of new mesh, mesh folded over upon itself with space between mesh where bowel could herniate, sutured mesh together, small bowel adherent to the mesh and had to be dissected off, recurrence of ventral hernia with obstruction, bowel obstruction secondary to incarcerated colon and small bowel and an incisional ventral hernia, extensive lysis of adhesions, extremely time consuming, tedious removal of mesh with cautery, and wound exploration with control of bleeding.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
This information was received as a part of an extensive mesh litigation submission to medtronic. The fda was notified of this large complaint receipt. Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target. 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 laparoscopic therapeutic treatment of a ventral incisional hernia and recurrent umbilical hernia. It was reported that after implant, the patient experienced pain, mesh erosion, mesh migration, hemorrhage, recurrence, mesh folded, mrsa, abscess, non-healing wound, chronic inflammation, adhesions, bowel obstruction, seroma, and bleeding. Post-operative patient treatment included mesh removal, placement of new mesh, incision and drainage, copious irrigation, laparoscopic incisional hernia repair, dissection of small bowel from hernia sac, dissection of adhesions and wound exploration with control of bleeding.
 
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. Product was used for therapeutic treatment of an incisional hernia. It was reported that after implant, the patient experienced multiple surgical revisions, recurrence, mesh folded over upon itself with space between mesh, small bowel adherent to the mesh, bowel obstruction secondary to incarcerated colon and extensive lysis of adhesions. Post-operative patient treatment included mesh removal, laparoscopic incisional hernia repair, dissection of small bowel and wound exploration with control of bleeding.
 
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Brand NameMESH SOFRADIM - PARIETEX¿ COMPOSITE MESH
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, CT 80301
3035816943
MDR Report Key7346629
MDR Text Key102707791
Report Number9615742-2018-00538
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040998
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 02/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2015
Device Model NumberPCO15
Device Catalogue NumberPCO15
Device Lot NumberPKE00344
Was Device Available for Evaluation? No
Date Manufacturer Received02/02/2022
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: 03/16/2018 Patient Sequence Number: 1
Treatment
PCO2015(LOT#: PJF00582), UNKABSTACK(LOT#: UNKNOWN)
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