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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 PCO15
Device Problems 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); Cyst(s) (1800); Purulent Discharge (1812); Fever (1858); Foreign Body Reaction (1868); Unspecified Infection (1930); Inflammation (1932); Muscle Weakness (1967); Pain (1994); Scar Tissue (2060); Hernia (2240); Discomfort (2330); Obstruction/Occlusion (2422); Ascites (2596); Abdominal Distention (2601); Fluid Discharge (2686); Fibrosis (3167); 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 a laparoscopic therapeutic treatment of a i incisional hernia. It was reported that after the implant, the patient experienced adhesions, hernia recurrence, abscess, infected mesh, mesh erosion, and pus. Post-operative patient treatment included hernia repair with mesh, explant of mesh, drainage of right flank abscess and of complex abdominal wall abscess, small bowel resection, abdominal wall reconstruction, multiple ventral hernia repaired with sutures, and revision surgery.
 
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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 Key12025495
MDR Text Key257519242
Report Number9615742-2021-01476
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 02/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2013
Device Model NumberPCO15
Device Catalogue NumberPCO15
Device Lot NumberPIJ00491
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: 06/18/2021 Patient Sequence Number: 1
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