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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 PCO2520
Device Problems Material Erosion (1214); Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Adult Respiratory Distress Syndrome (1696); Erosion (1750); Purulent Discharge (1812); Edema (1820); Hemorrhage/Bleeding (1888); Inflammation (1932); Nausea (1970); Necrosis (1971); Internal Organ Perforation (1987); Pain (1994); Sepsis (2067); Vomiting (2144); Discharge (2225); Hernia (2240); Injury (2348); Obstruction/Occlusion (2422); No Code Available (3191)
Event Type  Injury  
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 recurrent laparoscopic ventral incisional hernia. It was reported that after implant, the patient experienced hernia recurrence, leukocytosis, respiratory distress, abdominal pain, sepsis, adhesions, intense area of inflammation, small bowel perforation, small bowel obstruction, bowel edema, chronic pain, mesh erosion into viscera and abscesses. Post-operative patient treatment included revision surgeries, e xploratory laparotomy, venturi mask support, small bowel resection, drainage of multiple interloop abscesses, removal of abdominal mesh, negative pressure wound dressing, copious irrigation and debridement of skin/abdominal wall with closure of abdominal fascia, r epair of hernia with mesh, bilateral myocutaneous muscle flaps and lysis of adhesions.
 
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. The patient underwent an umbilical hernia repair with mesh. Treatment provided for these conditions included revision surgery with new mesh pco2520 implanted. The patient experienced recurrence and chronic pain.
 
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 recurrent laparoscopic ventral incisional hernia. It was reported that after implant, the patient experienced hernia recurrence, leukocytosis, respiratory distress, abdominal pain, sepsis, adhesions, intense area of inflammation, small bowel perforation, small bowel obstruction, bowel edema, chronic pain, mesh erosion into viscera and abscesses, serositis, necrosis, purulent material, fibrous adhesion formation, sepsis, fibrous exudate, nausea, vomiting, hemorrhagic material, and morbid obesity. Post-operative patient treatment included revision surgeries, exploratory laparotomy, venturi mask support, small bowel resection, drainage of multiple interloop abscesses, removal of abdominal mesh, negative pressure wound dressing, copious irrigation and debridement of skin/abdominal wall with closure of abdominal fascia, repair of hernia with mesh, bilateral myocutaneous muscle flaps and lysis of adhesions.
 
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. The patient underwent a hernia repair with mesh. The patient experienced recurrence and chronic pain.
 
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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
lisa hernandez
60 middletown ave
north haven, CT 06473
2034925563
MDR Report Key7120542
MDR Text Key258177216
Report Number9615742-2017-06108
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 12/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2010
Device Model NumberPCO2520
Device Catalogue NumberPCO2520
Device Lot NumberPFL00070
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/15/2019
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: 12/15/2017 Patient Sequence Number: 1
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