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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 PCO2520OS
Device Problems Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001); Material Split, Cut or Torn (4008)
Patient Problems Wound Dehiscence (1154); Abscess (1690); Adhesion(s) (1695); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Internal Organ Perforation (1987); Seroma (2069); Hernia (2240); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); No Code Available (3191); Nodule (4551); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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 of an incisional hernia. It was reported that after implant, the patient experienced recurrence, multiple fascial defect consistent with small swiss cheese like deformities through her midline fascia, seroma, small defect in omentum, extremely large pelvic mass, cystic degeneration of multiple uterine myomas, large piece of mesh in the upper abdomen that had portions of omentum adherent to it, dehiscence evidence of an incisional hernia repair, large subcutaneous abscess, bowel perforation, large loop of small bowel herniated fascia and had become obstructed, extensive adhesions, loss of domain with massive abdominal wall defect, left abdominal wall fascia retracted back significantly nearly to flank, non-healing wound, and necrosis. Post-operative patient treatment included repair of recurrent incarcerated incisional hernia with new mesh, seroma cavity was drained, removal of covidien mesh, dissection of omentum of mesh and resection of abdominal wall mesh, removal of the majority of the infracolic omentum, total abdominal hysterectomy, bilateral salpingo-oophorectomy, partial omentectomy, resection of approximately 40 cm of mid jejunum, wound vac closure of abdomen and abdominal washout, removal of old mesh, large recurrent incisional hernia repair with new strattice mesh, enteromy in distal ileum, resection of necrosis of skin edges, and skin was brought together in the midline with sutures followed by surgical clips on the skin.
 
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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 Key8491538
MDR Text Key141197856
Report Number9615742-2019-01084
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050187
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 01/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2014
Device Model NumberPCO2520OS
Device Catalogue NumberPCO2520OS
Device Lot NumberPJL00326
Was Device Available for Evaluation? No
Date Manufacturer Received01/12/2022
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: 04/08/2019 Patient Sequence Number: 1
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