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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 PCO2015OSX
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Unspecified Infection (1930); Necrosis (1971); Hernia (2240); Ascites (2596); 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 therapeutic treatment of a incarcerated recurrent ventral hernia.It was reported that after the implant, the patient experienced abdominal wall abscess, infected mesh, hernia recurrence, and adhesions.Post-operative patient treatment included ultrasound guided incision and drainage of abdominal wall abscess, wound debridement, removal of infected mesh, hernia repair with mesh (non-medtronic product), dissection of bowel from mesh that had adhered to it, ct guided percutaneous drainage of peritoneal abscess, and revision surgery.
 
Event Description
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a incarcerated recurrent ventral hernia.It was reported that after the implant, the patient experienced abdominal wall abscess, infected mesh, hernia recurrence, rare gram negative cocci, fibrosis, fat necrosis, chronic reactive changes, fluid collection with some associated air bubbles, nonviable tissue, fibrinous debris, peritoneal fluid, and adhesions.Post-operative patient treatment included ultrasound guided incision and drainage of abdominal wall abscess, wound debridement, removal of infected mesh, hernia repair with mesh (non-medtronic product), dissection of bowel from mesh that had adhered to it, ct guided percutaneous drainage of peritoneal abscess, admission to hospital, antibiotics, nonviable tissue debrided, wounds packed, drain placement, irrigation, removal of tacks/sutures, and revision surgery.
 
Manufacturer Narrative
Additional information: b2 (hospitalization), h6 (patient codes).Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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 Key12247655
MDR Text Key264136658
Report Number9615742-2021-01841
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10884521179806
UDI-Public10884521179806
Combination Product (y/n)N
PMA/PMN Number
K110816
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 08/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/30/2013
Device Model NumberPCO2015OSX
Device Catalogue NumberPCO2015OSX
Device Lot NumberPLG00406
Was Device Available for Evaluation? No
Date Manufacturer Received07/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age51 YR
Patient Weight169
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