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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 PCO2015
Device Problems Migration or Expulsion of Device (1395); Material Deformation (2976); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Erosion (1750); Purulent Discharge (1812); Erythema (1840); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Hernia (2240); Ascites (2596); Unspecified Tissue Injury (4559); 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 a ventral incisional hernia. It was reported that after implant, the patient experienced recurrence, infected mesh, infected abdominal wound, mesh migration, retraction of mesh, diastasis with eventration, adhesions, abscess, staphylococcus aureus, bacterial infection, fluid collection, skin inflamed, erythematous, purulent material, and mesh erosion into viscera. Post-operative patient treatment included explant of mesh, hernia repair with new mesh, partial omentectomy, removal of suture material, bilateral rectus myofascial release, and debridement of wound.
 
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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 Key11901138
MDR Text Key253161261
Report Number9615742-2021-01404
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
Type of Report Initial,Followup,Followup
Report Date 02/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2012
Device Model NumberPCO2015
Device Catalogue NumberPCO2015
Device Lot NumberPIA00465
Was Device Available for Evaluation? No
Date Manufacturer Received01/19/2022
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: 05/28/2021 Patient Sequence Number: 1
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