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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); Calcium Deposits/Calcification (1758); Cellulitis (1768); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Nausea (1970); Pain (1994); Pneumonia (2011); Seroma (2069); Urinary Retention (2119); Hernia (2240); Discomfort (2330); Impaired Healing (2378); Obstruction/Occlusion (2422); Ascites (2596); Abdominal Distention (2601); Weight Changes (2607); Fluid Discharge (2686); Cramp(s) /Muscle Spasm(s) (4521); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative

(b)(4). 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 incisional hernia. It was reported that after implant, the patient experienced adhesions, bacterial infection, cellulitis, abscess, serous drainage, pain, induration, infection, abdominal pain, gelatinous debris within wound, non-healing wound, abdominal cramping, coughing, copd, weight gain, nausea, diastasis, fluid collection, ascites, cholelithiasis, atherosclerotic disease, calcific cholelithiasis, hepatomegaly, hepatic steatosis, postop ileus, pneumonia, urinary retention, acute blood loss anemia, bloating, lump, tenderness, seroma, and recurrence. Post-operative patient treatment included revision surgery, wound vac, medication, abdominal wall debridement/irrigation, admission to hospital, hernia repair with mesh, fluid aspiration, lysis of adhesions, and mesh/tacks removal.

 
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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 Key11173288
MDR Text Key227001397
Report Number9615742-2021-00158
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 02/02/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/14/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/20/2013
Device MODEL NumberPCO3020
Device Catalogue NumberPCO3020
Device LOT NumberPIC00349
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/13/2021
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: 01/14/2021 Patient Sequence Number: 1
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