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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PARIETEX; MESH, SURGICAL, POLYMERIC
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SOFRADIM PRODUCTION SAS PARIETEX; MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCO2015X
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Abscess (1690); Cellulitis (1768); Purulent Discharge (1812); Fever (1858); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Staphylococcus Aureus (2058); Hernia (2240); Injury (2348); Impaired Healing (2378); Post Operative Wound Infection (2446); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(4) (multiple surgical revisions).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.The patient experienced multiple surgical revisions, abdominal pain, abdominal wall cellulitis, abscess around the mesh, infection, incision and drainage of abdominal wall abscess, purulent and gelatinous material found, wound vac placed, and non-healing wound.
 
Manufacturer Narrative
This information was received as a part of an extensive mesh litigation submission to medtronic. the fda was notified of this large complaint receipt.  due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.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 of ventral hernia.The patient experienced multiple surgical revisions, abdominal pain, abdominal wall cellulitis, abscess around the mesh, infection, incision and drainage of abdominal wall abscess, purulent and gelatinous material found, wound vac placed, and non-healing wound.
 
Manufacturer Narrative
This information was received as a part of an extensive mesh litigation submission to medtronic.The fda was notified of this large complaint receipt.Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.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 ventral hernia.It was reported after implant, the patient experienced recurrence, abdominal pain, abdominal wall cellulitis, abscess around the mesh, infection, purulent and gelatinous material found, and non-healing wound.Post-operative patient treatment included revision surgery, excision of infected mesh with new ethicon physiomesh implanted, incision and drainage of abdominal wall abscess and wound vac placed.
 
Event Description
The patient's attorney alleged a deficiency against the device.The product was used for therapeutic treatment of ventral hernia.It was reported after implant, the patient experienced recurrence, abdominal pain, leukocytosis, fever, abdominal wall cellulitis, abscess around the mesh, hemorrhage, infection, (b)(6), purulent and gelatinous material found, and non-healing wound.Post-operative patient treatment included revision surgery, excision of infected mesh with new ethicon physiomesh implanted, complex closure of abdominal wound, incision and drainage of abdominal wall abscess, wound debridement, and wound vac placed.Relevant tests/laboratory data: (b)(6) 2013: op note- ct scan showed abscess around the mesh.(b)(6) 2013: pathology noted mesh as hemorrhagic with metal clips attached.On (b)(6) 2013: ct scan showed large subcutaneous abscess with possible extension.(b)(6) 2013: wound cultures returned on (b)(6) 2013 positive for (b)(6).
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
PARIETEX
Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR  01600
MDR Report Key7446959
MDR Text Key106047165
Report Number9615742-2018-00900
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10884521179769
UDI-Public10884521179769
Combination Product (y/n)N
PMA/PMN Number
K110815
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup,Followup,Followup
Report Date 11/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2014
Device Model NumberPCO2015X
Device Catalogue NumberPCO2015X
Device Lot NumberPMF00679
Was Device Available for Evaluation? No
Date Manufacturer Received05/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age40 YR
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