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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 PCO15
Device Problems Migration or Expulsion of Device (1395); Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Ischemia (1942); Necrosis (1971); Internal Organ Perforation (1987); Pain (1994); Perforation (2001); Discharge (2225); Hernia (2240); Peritonitis (2252); Injury (2348); Impaired Healing (2378); Bowel Perforation (2668); 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.
 
Event Description
The patient's attorney alleged a deficiency against the device. Product was used for therapeutic treatment of a supraumbilical midline ventral hernia. It was reported that after implant, the patient experienced recurrence, pain, dense adhesions, necrotic ileum and small bowel, open draining wound, perforated appendix, abdominal pain, and chronic mesenteric ischemia. Post-operative patient treatment included revision surgeries, recurrence, repair of hernia with mesh, exploratory laparotomy, lysis of adhesions, resection of 35 cm of small bowel, placement of wound vac, primary anastomosis of the ileum, appendectomy, small bowel resection, enteroerostomy, abdominal closure, and wound vac.
 
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. The patient had revision surgery 3 years and 5 months post-surgery. The patient experienced pain, hernia recurrence, revision surgeries, significant adhesions to bowels and open draining wound. External contact and facility is not available because source document is not received.
 
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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 80301
3035816943
MDR Report Key7108066
MDR Text Key250959459
Report Number9615742-2017-05996
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 Other,Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 01/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPCO15
Device Catalogue NumberPCO15
Device Lot NumberPHG00327
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: 12/12/2017 Patient Sequence Number: 1
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