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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 PCO12
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Purulent Discharge (1812); Granuloma (1876); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Scar Tissue (2060); Seroma (2069); Hernia (2240); Distress (2329); Discomfort (2330); Impaired Healing (2378); Ascites (2596); Fluid Discharge (2686); Foreign Body In Patient (2687); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); 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 laparoscopic therapeutic treatment of a ventral incisional hernia. It was reported that after implant, the patient experienced granulation, giant cell reaction, necrosis, foamy macrophage reaction, multinucleated giant cell reaction, chronic inflammation, scarring, foreign bodies, abdominal pain, swelling, redness, tenderness, abscess, purulent material, fluid collection, adhesions, seroma, drainage, scar tissue formation, infection, non-healing wound, distress, discomfort, and recurrence. Post-operative patient treatment included revision surgery, mesh removal, wound debridement, debridement of abdominal wall/fascia/muscle/mesh, wound vac, excision of granulation, endoscopic separation of components-bilateral (creation of myocutaneous flap), lysis of adhesions, admission to hospital, and hernia repair with mesh.

 
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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 Key11548187
MDR Text Key241740903
Report Number9615742-2021-00632
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
Report Date 04/23/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/22/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/31/2012
Device MODEL NumberPCO12
Device Catalogue NumberPCO12
Device LOT NumberPHF00316
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/07/2021
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: 03/22/2021 Patient Sequence Number: 1
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