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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 PCO2520X
Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Abscess (1690); Anemia (1706); Bacterial Infection (1735); Purulent Discharge (1812); Erythema (1840); Fistula (1862); Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Pain (1994); Staphylococcus Aureus (2058); Vomiting (2144); Hernia (2240); Injury (2348); Blood Loss (2597); Unspecified Tissue Injury (4559)
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 an incisional hernia. It was reported that after implant, the patient experienced a large abdominal wall abscess, purulent material, foreign body granulomatous inflammation, mrsa, inflammation, abdominal pain, erythema, nausea, vomiting, anemia, blood loss, and loose mesh. Post-operative patient treatment included revision surgery, admission to hospital, antibiotics/medication, wound vac, transfusion, and mesh removal.
 
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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
tracy landers
5920 longbow drive
boulder,co, CT 80301
3035816943
MDR Report Key10637122
MDR Text Key210062815
Report Number9615742-2020-02281
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110815
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/30/2013
Device Model NumberPCO2520X
Device Catalogue NumberPCO2520X
Device Lot NumberPLH00403
Was Device Available for Evaluation? No
Date Manufacturer Received11/17/2021
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: 10/06/2020 Patient Sequence Number: 1
Treatment
UNKNOWN ABSORBATACK (LOT#UNKNOWN)
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