• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PARIETEX MESH, SURGICAL, POLYMERIC

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SOFRADIM PRODUCTION SAS PARIETEX MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCO12X
Device Problems Loss of or Failure to Bond (1068); Material Erosion (1214); Migration or Expulsion of Device (1395); Material Perforation (2205); Material Integrity Problem (2978); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Adhesion(s) (1695); Bacterial Infection (1735); Erosion (1750); Emotional Changes (1831); Fistula (1862); Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Muscle Weakness (1967); Necrosis (1971); Nerve Damage (1979); Neuropathy (1983); Internal Organ Perforation (1987); Pain (1994); Perforation (2001); Scar Tissue (2060); Scarring (2061); Hernia (2240); Injury (2348); Scar Excision (2358); Deformity/ Disfigurement (2360); Impaired Healing (2378); Blood Loss (2597); 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 ventral/incisional hernia. It was reported that after implant, the patient experienced recurrence, bleeding out severe enough to be life threatening, hypertrophic scarring, obliteration of the umbilicus, scar tissue, adhesions, failure of mesh, physical deformity, mesh erosion, mesh contraction, infection, fistula, inflammation, organ perforation, dyspareunia, neuropathy, nerve damage, pain, open wound, foreign body reaction, necrotic fat, large diastasis and mental anguish. Post-operative patient treatment included revision surgery, excision of mesh, excision of scar tissue, release of adhesions, repair of hernia, bilateral rectus abdominus advancement flaps, fasciocutaneous flap advancement, wound vac, excision of hypertrophic thinned scar area overlying hernia sac and pain control and open wound was debrided with excision of skin, soft tissue and necrotic fat.
 
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 ventral/incisional hernia. It was reported that after implant, the patient experienced recurrence, bleeding out severe enough to be life threatening, hypertrophic scarring, obliteration of the umbilicus, scar tissue, adhesions, failure of mesh, physical deformity, mesh erosion, mesh contraction, infection, fistula, inflammation, organ perforation, dyspareunia, neuropathy, nerve damage, pain, open wound,bleeding, foreign body reaction, necrotic fat, large diastasis and mental anguish. Post-operative patient treatment included revision surgery, excision of mesh, excision of scar tissue, release of adhesions, repair of hernia, bilateral rectus abdominus advancement flaps, fasciocutaneous flap advancement, wound vac, excision of hypertrophic thinned scar area overlying hernia sac and pain control and open wound was debrided with excision of skin, soft tissue and necrotic fat.
 
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 ventral/incisional hernia. It was reported that after implant, the patient experienced recurrence, bleeding out severe enough to be life threatening, hypertrophic scarring, obliteration of the umbilicus, scar tissue, adhesions, failure of mesh, physical deformity, mesh erosion, mesh contraction, infection, fistula, inflammation, organ perforation, dyspareunia, neuropathy, nerve damage, pain, open wound, and mental anguish. Post-operative patient treatment included revision surgery, excision of mesh, excision of scar tissue, release of adhesions, repair of hernia, bilateral rectus abdominus advancement flaps, fasciocutaneous flap advancement, wound vac, and pain control.
 
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 was implanted with mesh in an attempt to repair an incisional hernia. The patient underwent an additional surgery approximately 3 months post op after the incision from her hernia repair broke open and she began to bleed out. The bleeding was severe enough to be considered life threatening. During the surgery it was noted that the upper portion of the mesh was "relatively" incorporated, however the lower portion was loose. The lower portion was completely excised during this surgery and sent to pathology. Approximately 1 year and 6 months post op the patient underwent another surgery to repair an abdominal wall hernia recurrence with hypertrophic scarring, obliteration of the umbilicus and a large reducible hernia. This procedure included the excision of a significant amount of scar tissue and the release of multiple adhesions. The mesh failed, causing serious injury and portions of the mesh had to be surgically removed via invasive surgery, and necessitated an additional invasive surgery to repair the hernia that the mesh was initially implanted to treat. The patient suffered and will continue to suffer both physical injury and pain and mental anguish, permanent and severe scarring. The patient has suffered permanent injury and permanent and substantial physical deformity. The patient sustained injuries including, but not limited to mesh erosion, mesh contraction, infection, fistula, inflammation, scar tissue, organ perforation, recurrence, dyspareunia, blood loss, neuropathic and other acute and chronic nerve damage and pain, requiring patient to undergo intensive medical treatment, including but not limited to operations to locate and remove mesh, operations to attempt to repair organs, tissue, and nerve damage, the use of pain control and other medications.
 
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 ventral/incisional hernia. It was reported that after implant, the patient experienced additional surgery approximately 3 months post op after the incision from her hernia repair broke open and she began to bleed out. The bleeding was severe enough to be considered life threatening. The lower portion of mesh was completely excised during this surgery and sent to pathology. Approximately 1 year and 6 months post op the patient underwent another surgery to repair an abdominal wall hernia recurrence with hypertrophic scarring, obliteration of the umbilicus and a large reducible hernia. This procedure included the excision of a significant amount of scar tissue and the release of multiple adhesions. The mesh failed, causing serious injury and portions of the mesh had to be surgically removed via invasive surgery and necessitated an additional invasive surgery to repair the hernia that the mesh was initially implanted to treat. The patient suffered and will continue to suffer both physical injury and pain and mental anguish, permanent and severe scarring. The patient has suffered permanent injury and permanent/substantial physical deformity. The patient sustained injuries including, but not limited to mesh erosion, mesh contraction, infection, fistula, inflammation, scar tissue, organ perforation, recurrence, dyspareunia, blood loss, neuropathic and other acute and chronic nerve damage and pain. Post-operative patient treatment included operations to locate and remove mesh, operations to attempt to repair organs, tissue, nerve damage, the use of pain control, and the use of other medications.
 
Manufacturer Narrative
(b)(4). 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 ventral/incisional hernia. It was reported that after implant, the patient experienced recurrence, bleeding out severe enough to be life threatening, hypertrophic scarring, obliteration of the umbilicus, scar tissue, adhesions, failure of mesh, physical deformity, mesh erosion, mesh contraction, infection, fistula, inflammation, organ perforation, dyspareunia, neuropathy, nerve damage, pain, open wound, foreign body reaction, necrotic fat, large diastasis, bacterial infection, mesh migration and mental anguish. Post-operative patient treatment included revision surgery, excision of mesh, excision of scar tissue, release of adhesions, repair of hernia, bilateral rectus abdominis advancement flaps, fasciocutaneous flap advancement, wound vac, excision of hypertrophic thinned scar area overlying hernia sac and pain control and open wound was debrided with excision of skin, soft tissue and necrotic fat.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. 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 was implanted with mesh in an attempt to repair an incisional hernia. The patient underwent an additional surgery approximately 3 months post op after the incision from her hernia repair broke open and she began to bleed out. The bleeding was sever enough to be considered life threatening. During the surgery it was noted that the upper portion of the mesh was "relatively" incorporated, however the lower portion was loose. The lower portion was completely excised during this surgery and sent to pathology. Approximately 1 year and 6 months post op the patient underwent another surgery to repair an abdominal wall hernia recurrence with hypertrophic scarring, obliteration of the umbilicus and a large reducible hernia. This procedure included the excision of a significant amount of scar tissue and the release of multiple adhesions. The mesh failed, causing serious injury and portions of the mesh had to be surgically removed via invasive surgery, and necessitated an additional invasive surgery to repair the herniathat the mesh was initially implanted to treat. The patient suffered and will continue to suffer both physical injury and pain and m ental anguish, permanent and severe scarring. The patient has suffered permanent injury and permanent and substantial physical deformity. The patient sustained injuries including, but not limited to mesh erosion, mesh contraction, infection, fistula, inflammation, scar tissue, organ perforation, recurrence, dyspareunia, blood loss, neuropathic and other acute and chronic nerve damage and pain, requiring patient to undergo intensive medical treatment, including but not limited to operations to locate and remove mesh, operations to attempt to repair organs, tissue, and nerve damage, the use of pain control and other medications.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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, CT 80301
3035816943
MDR Report Key6866214
MDR Text Key247302773
Report Number9615742-2017-05233
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 Other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 01/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2019
Device Model NumberPCO12X
Device Catalogue NumberPCO12X
Device Lot NumberPOH0208X
Was Device Available for Evaluation? No
Date Manufacturer Received01/05/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/30/2014
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: 09/14/2017 Patient Sequence Number: 1
-
-