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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 PCO12
Device Problems Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Erosion (1750); Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Staphylococcus Aureus (2058); Scar Tissue (2060); Discharge (2225); Hernia (2240); Ulcer (2274); Injury (2348); Impaired Healing (2378); Blood Loss (2597); Fluid Discharge (2686); No Code Available (3191); 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 resulting in an unspecified adverse outcome. Product was used for therapeutic treatment. Preoperative and postoperative diagnosis was ventral incisional hernia. The procedure performed was laparoscopic repair of ventral, incisional hernia. The patient experienced removal or revision surgery resulting from complications from mesh.
 
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 ventral incisional hernia. It was reported that after implant, the patient experienced recurrence, infection, granulation tissue with acute and chronic inflammation, abdominal wall abscess, mucoid drainage, wound with exposed mesh and open wound. Post-operative patient treatment included debridement of abdominal wall wound, mesh excision and wound vac placement, removal of prior mesh and placement of new cook biodesign mesh.
 
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 laparoscopic therapeutic treatment of a ventral incisional hernia. It was reported that after implant, the patient experienced recurrence, infection, (b)(6), granulation tissue with acute and chronic inflammation, bleeding gastric ulcer, abdominal wall abscess and abscesses that continued developing along the edges of the mesh, mucoid drainage, adhesions, wound with exposed mesh and open wound. Post-operative patient treatment included debridement of abdominal wall wound, mesh excision and wound vac placement, subtotal gastrectomy, removal of prior mesh and placement of new cook biodesign mesh.
 
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 a ventral incisional hernia. It was reported that after implant, the patient experienced recurrence, infection, (b)(6), granulation tissue with acute and chronic inflammation, bleeding gastric ulcer, abdominal wall abscess and abscesses that continued developing along the edges of the mesh, mucoid drainage, adhesions, wound with exposed mesh, pain, mesh erosion, scarification, mesh encapsulation, lack of adequate ingrowth, and open wound. Post-operative patient treatment included debridement of abdominal wall wound, mesh excision and wound vac placement, subtotal gastrectomy, removal of prior mesh and placement of new cook biodesign mesh.
 
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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 Key7410034
MDR Text Key104799041
Report Number9615742-2018-00814
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 01/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2014
Device Model NumberPCO12
Device Catalogue NumberPCO12
Device Lot NumberPJH00448
Was Device Available for Evaluation? No
Date Manufacturer Received12/29/2021
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: 04/09/2018 Patient Sequence Number: 1
Treatment
174006(LOT#: P0C0160)
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