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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 PCO9X
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Low Blood Pressure/ Hypotension (1914); Hypoxia (1918); Pain (1994); Hernia (2240); Injury (2348); No Code Available (3191); Cough (4457); 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 hernia. It was reported that after implant, the patient experienced recurrence, adhesions and pain. Treatment provided for these conditions include revision surgery.
 
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 an incarcerated ventral hernia. It was reported that after implant, the patient experienced recurrence, adhesions, pain, leukocytosis, spleen injury, white count of 16. 3, mild central vascular congestion, patchy atelectasis/infiltrates in both lung bases, hypotension, and nonproductive cough with increased oxygen demand. Post operative treatment include diaphragmatic hernia repair, nissen fundoplication, extensive enterolysis, splenorrhaphy, lap converted to open recurrent hiatal hernia repair, extensive lysis of adhesions, antibiotics, and oxygen.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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 an incarcerated ventral hernia. It was reported that after implant, the patient experienced recurrence, adhesions, pain, leukocytosis, white count of 16. 3, mild central vascular congestion, patchy atelectasis/infiltrates in both lung bases, hypotension, and nonproductive cough with increased oxygen demand. Post operative treatment include diaphragmatic hernia repair, nissen fundoplication, extensive enterolysis, splenorrhaphy, lap converted to open recurrent hiatal hernia repair, extensive lysis of adhesions, antibiotics, and oxygen.
 
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Brand NamePARIETEX
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, CT 80301
3035816943
MDR Report Key7926407
MDR Text Key122341824
Report Number9615742-2018-02196
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110815
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,Followup
Report Date 01/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2018
Device Model NumberPCO9X
Device Catalogue NumberPCO9X
Device Lot NumberPNI0181X
Was Device Available for Evaluation? No
Date Manufacturer Received12/15/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/14/2013
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: 10/02/2018 Patient Sequence Number: 1
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