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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 Problems Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Arrhythmia (1721); Bacterial Infection (1735); Purulent Discharge (1812); Emotional Changes (1831); Erythema (1840); Fistula (1862); Foreign Body Reaction (1868); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Staphylococcus Aureus (2058); Seroma (2069); Swelling (2091); Tachycardia (2095); Discharge (2225); Hernia (2240); Discomfort (2330); Injury (2348); Impaired Healing (2378); Palpitations (2467); Ascites (2596); Fluid Discharge (2686); Fibrosis (3167); No Code Available (3191); 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 incarcerated incisional hernia. It was reported that after implant, the patient experienced postop wound seroma, abdominal wall abscess, fluid collection in abdomen and subcutaneous tissues, draining sinus tracts, chronic fistula, and fibrinous exudate. Post-operative patient treatment included incision and drainage, wound vac twice, debridement, fibrinous exudate removal, and abdominal wall mesh 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
tracy landers
5920 longbow drive
boulder, CO 80301
3035816943
MDR Report Key8324165
MDR Text Key135678210
Report Number9615742-2019-00274
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040998
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 10/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2013
Device Model NumberPCO3020
Device Catalogue NumberPCO3020
Device Lot NumberPIH00249
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/22/2021
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: 02/08/2019 Patient Sequence Number: 1
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