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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 PCO2520OS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Corneal Pannus (1447); Adhesion(s) (1695); Bacterial Infection (1735); Purulent Discharge (1812); Fistula (1862); Unspecified Infection (1930); Pain (1994); Staphylococcus Aureus (2058); Scar Tissue (2060); Scarring (2061); Seroma (2069); Hernia (2240); Injury (2348); Impaired Healing (2378); Post Operative Wound Infection (2446); No Code Available (3191); 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 resulting in an unspecified adverse outcome. Product was used for therapeutic treatment. On (b)(6) 2014 the patient underwent surgical revision for removal of infected mesh and repair of recurrent incisional hernia. The pre-op and post-op diagnosis was nonhealing abdominal wound with infected mesh. (b)(6) 2014 - the patient underwent a subsequent revision for abdominal wall reconstruction with bilateral rectus muscle flap. The patient developed a large open draining area that the surgeons said was related to the mesh. The pre-op and post-op diagnosis was infected abdominal mesh from hernia repair and large abdominal pannus. The patient experienced pain, adhesions, reherniation, non-healing wound, and infection. The original implantation was on (b)(6) 2013. Eight months in between the two surgeries.
 
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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 Key7388856
MDR Text Key104069350
Report Number9615742-2018-00641
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050187
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 02/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPCO2520OS
Device Catalogue NumberPCO2520OS
Device Lot NumberPKK00013
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: 04/02/2018 Patient Sequence Number: 1
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