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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS PARIETEX MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCO2015X
Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Erosion (1750); Cellulitis (1768); Fistula (1862); High Blood Pressure/ Hypertension (1908); Hypoxia (1918); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pleural Effusion (2010); Seroma (2069); Tachycardia (2095); Hernia (2240); Respiratory Failure (2484); Ascites (2596); 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 therapeutic treatment of an incisional hernia. It was reported that after implant, the patient experienced adhesions, fistula, migration, mesh erosion into viscera, gas accumulation, infection, abscess, bacterial infection, chronic inflammation, fat necrosis, fluid collection, seroma, free air, bilateral pleural effusions with adjacent atelectasis, cellulitis, swelling, abdominal pain, tachycardic, hypertensive, acute hypoxic respiratory failure, and recurrence. Post-operative patient treatment included removal of mesh, small bowel resection, abdominal wall debridement, hernia repair with mesh, drain placement, admission to hospital, medication, bilateral retrorectus compartment separation, appendectomy, en bloc resection of abdominal wall mesh/omentum/small bowel involvement enterocutaneous fistula, endotracheal/nasogastric tubes in place, picc, drainage of seroma, and lysis of adhesions.

 
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Brand NamePARIETEX
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 Key11757834
MDR Text Key248398403
Report Number9615742-2021-00947
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK110815
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 04/30/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/30/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2014
Device MODEL NumberPCO2015X
Device Catalogue NumberPCO2015X
Device LOT NumberPMB00053
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/14/2021
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: 04/30/2021 Patient Sequence Number: 1
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