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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 PCO15X
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Abscess (1690); Erosion (1750); Fistula (1862); Foreign Body Reaction (1868); Unspecified Infection (1930); Pain (1994); Injury (2348); Impaired Healing (2378); Ascites (2596); Fluid Discharge (2686); No Code Available (3191); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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.
 
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 umbilical hernia. It was reported that after implant, the patient experienced infection, abscess, open wound, fluid collections anterior to fascia, fibroadipose tissue, foreign body giant cell reaction and severe pain. Post-operative patient treatment included revision/removal surgery of infected mesh, hospitalizations, incision and drainage of abscess and wound vac.
 
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 umbilical hernia. It was reported that after implant, the patient experienced infection, abscess, open wound and severe pain. Post-operative patient treatment included revision/removal surgery of infected mesh, hospitalizations, incision and drainage of abscess and wound vac.
 
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 umbilical hernia repair with mesh. She had revision surgery 2 years and 1 month post-surgery. The patient experienced removal, infection, hospitalizations and severe pain.
 
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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 Key7140611
MDR Text Key250968489
Report Number9615742-2017-06150
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 12/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2017
Device Model NumberPCO15X
Device Catalogue NumberPCO15X
Device Lot NumberPMK00085
Was Device Available for Evaluation? No
Date Manufacturer Received11/17/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/24/2012
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: 12/21/2017 Patient Sequence Number: 1
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