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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 PCO3020X
Device Problems Migration or Expulsion of Device (1395); Product Quality Problem (1506); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Nausea (1970); Pain (1994); Scar Tissue (2060); Vomiting (2144); Hernia (2240); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); No Code Available (3191); 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 hernia. It was reported that in (b)(6) 2015, the patient experienced small bowel obstruction and underwent extensive lysis of adhesions. Treatment provided for these conditions in (b)(6) 2018 include explant, extensive lysis of adhesions lasting approximately 3 hours, recurrent ventral incisional hernia repair with new mesh, complex closure of abdominal wall, and wound vac placement.
 
Event Description
The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of an incisional hernia. It was reported that after implant, the patient experienced abdominal pain, nausea, vomiting, recurrence, chronic cholecystitis with cholelithiasis, adhesions, small bowel obstruction, scarring, tented mesh, and open wound. Post-operative patient treatment included incarcerated incisional hernia repair, lysis of adhesions, small bowel resection, loops of small bowel were taken down (terminal ileum), exploratory laparotomy, excision of multiple mesh devices, and placement of prevena incisional wound vac.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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 laparoscopic therapeutic treatment of an incisional hernia. It was reported that after implant, the patient experienced abdominal pain, pain, nausea, vomiting, recurrence, chronic cholecystitis with cholelithiasis, adhesions, small bowel obstruction, scarring, tented mesh, and open wound. Post-operative patient treatment included incarcerated incisional hernia repair, lysis of adhesions, small bowel resection, loops of small bowel were taken down (terminal ileum), exploratory laparotomy, excision of multiple mesh devices, and placement of prevena incisional wound vac.
 
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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 80301
3035816943
MDR Report Key8167848
MDR Text Key130462285
Report Number9615742-2018-02793
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 12/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2018
Device Model NumberPCO3020X
Device Catalogue NumberPCO3020X
Device Lot NumberPNH0612X
Was Device Available for Evaluation? No
Date Manufacturer Received11/15/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/07/2013
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: 12/16/2018 Patient Sequence Number: 1
Treatment
UNKABSTACK(LOT#: UNKNOWN)
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