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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 PCO2520
Device Problems Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Abscess (1690); Adhesion(s) (1695); Erosion (1750); Purulent Discharge (1812); Fistula (1862); Foreign Body Reaction (1868); Granuloma (1876); Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Seroma (2069); Discharge (2225); Hernia (2240); Discomfort (2330); Injury (2348); Impaired Healing (2378); Abdominal Distention (2601); Fibrosis (3167); No Code Available (3191)
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 recurrence, draining sinus, subcutaneous abscess drainage with seropurulent material, adhesions, hematoma, draining serous material from incision, seroma, lateral hernia, mesh erosion, granuloma and pain. Post-operative patient treatment included excision of draining sinus, incision and drainage of wound abscess, mesh edges excised, incisional hernia recurrence requiring placement of new mesh, lysis of adhesions, aspiration of hematoma and seroma, excision of small bowel with mesh erosion, excision of old mesh, adhesions removed, partial excision of mesh, as well as excision of suture sinus and suture granuloma.
 
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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, CT 80301
3035816943
MDR Report Key8782915
MDR Text Key150805129
Report Number9615742-2019-02515
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 11/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPCO2520
Device Catalogue NumberPCO2520
Device Lot NumberPIK00609
Was Device Available for Evaluation? No
Date Manufacturer Received11/03/2021
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: 07/11/2019 Patient Sequence Number: 1
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