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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 PCO3020
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Anemia (1706); Bacterial Infection (1735); Purulent Discharge (1812); Fever (1858); Fistula (1862); Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Inflammation (1932); Necrosis (1971); Perforation (2001); Pleural Effusion (2010); Scarring (2061); Sepsis (2067); Tachycardia (2095); Thrombosis (2100); Hernia (2240); Peritonitis (2252); Injury (2348); Obstruction/Occlusion (2422); Respiratory Failure (2484); Ascites (2596); Abdominal Distention (2601); Fibrosis (3167); No Code Available (3191)
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 a recurrent ventral incisional hernia. It was reported that after implant, the patient experienced adhesions, bowel obstruction, recurrence, chronic pancreatitis, scarred bowel, acute respiratory failure/mechanical ventilation, tachycardia, sepsis secondary to peritonitis secondary to bowel resection secondary to bowel obstruction, possible perforation, dvt, kidney injury, pleural effusion/atelectasis, anemia, fever, elevated wbc, sanguineous drainage, peritoneal abscess, and strawberry colored purulent fluid. Post-operative patient treatment included revision and removal surgeries, and resection of sigmoid <(>&<)> descending colon, terminal ileum and right colon.

 
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 recurrent ventral incisional hernia. It was reported that after implant, the patient experienced adhesions, bowel obstruction, recurrence, chronic pancreatitis, scarred bowel, acute respiratory failure/mechanical ventilation, tachycardia, sepsis secondary to peritonitis secondary to bowel resection secondary to bowel obstruction, possible perforation, dvt, kidney injury, pleural effusion/atelectasis, anemia, fever, elevated wbc, sanguineous drainage, peritoneal abscess, fibrosis, fat necrosis, foreign body giant cell reaction, segmental constriction, acute hemorrhage, and strawberry colored purulent fluid. Post-operative patient treatment included revision and removal surgeries, and resection of sigmoid <(>&<)> descending colon, terminal ileum and right colon.

 
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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
lisa hernandez
60 middletown ave
north haven, CT 06473
2034925563
MDR Report Key8938178
MDR Text Key155778187
Report Number9615742-2019-02885
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK040998
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/17/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/27/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPCO3020
Device Catalogue NumberPCO3020
Device LOT NumberPGL00089
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/03/2020
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: 08/27/2019 Patient Sequence Number: 1
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