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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 PCO1510X
Device Problems Migration or Expulsion of Device (1395); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Anemia (1706); Bacterial Infection (1735); Emotional Changes (1831); Fistula (1862); Hemorrhage/Bleeding (1888); Failure of Implant (1924); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Staphylococcus Aureus (2058); Discharge (2225); Hernia (2240); Discomfort (2330); Injury (2348); Impaired Healing (2378); Post Operative Wound Infection (2446); Blood Loss (2597); Fluid Discharge (2686); No Code Available (3191); Hyponatremia (4494); Unspecified Tissue Injury (4559)
Event Type  Injury  
Manufacturer Narrative
Patient code (b)(4) (revision, recurrence).To date, the incident sample has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.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 has had a surgical revision, adhesion, chronic abdominal pain, hernia recurrence, open draining wound and infection.
 
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 a ventral hernia.It was reported that after implant, the patient experienced adhesions, enterocutaneous fistula through midline wound, unincorporated mesh, chronic abdominal pain, hernia recurrence, open draining wound, mrsa, mesh free floating, small bowel serosal injury, necrotic track, acute blood loss anemia, hyponatremia, and infection.Post-operative patient treatment included revision surgery, small bowel resection, serosal injury repair, incision and drainage of wound, wound vac, component separation, lysis of adhesions, necrotic track debrided, removal of mesh and recurrence repair with placement of new mesh.
 
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.Concomitant medical products: (lot# pli00338).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 hernia.It was reported that after implant, the patient experienced adhesions, enterocutaneous fistula through midline wound, unincorporated mesh, chronic abdominal pain, hernia recurrence, open draining wound and infection.Post-operative patient treatment included revision surgery, small bowel resection, removal of mesh and recurrence repair with placement of new mesh.
 
Event Description
The patient's attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a ventral hernia.It was reported that after implant, the patient experienced adhesions, enterocutaneous fistula through midline wound, unincorporated mesh, chronic abdominal pain, hernia recurrence, open draining wound, mrsa, mesh free floating, small bowel serosal injury, necrotic track, acute blood loss anemia, hyponatremia, mental pain, physical pain, suffering, disability, impairment, loss of enjoyment of life, loss of care/comfort/consortium, defective device, failure of mesh, and infection.Post-operative patient treatment included revision surgery, small bowel resection, serosal injury repair, incision and drainage of wound, wound vac, component separation, lysis of adhesions, necrotic track debrided, removal of mesh and recurrence repair with placement of new mesh.
 
Manufacturer Narrative
Additional information: b2 (added disability), b5, d8, g3, h6 correction: d1, g1 (all manufacturers information) 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.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 Key7053571
MDR Text Key92785991
Report Number9615742-2017-05832
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10884521179707
UDI-Public10884521179707
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 10/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/01/2014
Device Model NumberPCO1510X
Device Catalogue NumberPCO1510X
Device Lot NumberPMB00018
Was Device Available for Evaluation? No
Date Manufacturer Received09/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
PCO2520X PARIETEX PCOX 25X20CM X1; UNKABSTACK(LOT#: UNKNOWN)
Patient Outcome(s) Other; Required Intervention; Disability;
Patient Age41 YR
Patient Weight136
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