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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 PCO3020
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Bacterial Infection (1735); Unspecified Infection (1930); Pain (1994); Staphylococcus Aureus (2058); Hernia (2240); Injury (2348); Impaired Healing (2378); Unspecified Tissue Injury (4559)
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 after implant, the patient experienced adhesions, infection, and recurrence. Treatment provided for these conditions include mesh removal.
 
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 underlay implant, the patient experienced adhesions, infection, open wound, mrsa, chronic pain, exposed mesh and recurrence. Post-operative patient treatment included revision surgery, mesh removal, rives-stoppa repair with release of posterior sheath and transversus abdominis musculature, two bilateral muscle advancements, myofascial advancement of rectus muscle to midline for closure of hernia and placement of retrorectus mesh, finally debridement of skin and primary closure and lysis of adhesions.
 
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 inguinal hernia. It was reported that after implant, the patient experienced adhesions, infection, open wound, and recurrence. Post-operative patient treatment included revision surgery, mesh removal, and lysis of adhesions.
 
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 underlay implant, the patient experienced adhesions, infection, open wound, mrsa, and recurrence. Post-operative patient treatment included revision surgery, mesh removal, rives-stoppa repair with release of posterior sheath and transversus abdominis musculature, two bilateral muscle advancements, myofascial advancement of rectus muscle to midline for closure of hernia and placement of retrorectus mesh, finally debridement of skin and primary closure 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.
 
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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
tracy landers
5920 longbow drive
boulder,co, CT 80301
3035816943
MDR Report Key8167818
MDR Text Key130462073
Report Number9615742-2018-02774
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040998
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
Report Date 01/04/2022
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 Date07/31/2015
Device Model NumberPCO3020
Device Catalogue NumberPCO3020
Device Lot NumberPKH00274
Was Device Available for Evaluation? No
Date Manufacturer Received12/15/2021
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: 12/16/2018 Patient Sequence Number: 1
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