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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 PCO1510OS
Device Problems Migration or Expulsion of Device (1395); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Wound Dehiscence (1154); Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Erosion (1750); Death (1802); Purulent Discharge (1812); Edema (1820); Emotional Changes (1831); Fistula (1862); Low Blood Pressure/ Hypotension (1914); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Necrosis (1971); Nerve Damage (1979); Internal Organ Perforation (1987); Pain (1994); Sepsis (2067); Vomiting (2144); Hernia (2240); Distress (2329); Injury (2348); Deformity/ Disfigurement (2360); Depression (2361); Impaired Healing (2378); Obstruction/Occlusion (2422); Abdominal Distention (2601); Fluid Discharge (2686); No Code Available (3191); Constipation (3274); Respiratory Insufficiency (4462); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Death  
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. It was reported that after a procedure where this device was implanted, the patient experienced bowel obstruction; bowel perforation; bowel resection; attempted mesh removal surgery; sepsis; nerve damage; loss of muscle control; death. No information has been provided at this time in regards to the date of death and cause. After the original procedure, additional potentially related procedures were performed, including removal surgery.
 
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 ventral incisional hernia. It was reported that after a procedure where this device was implanted, the patient experienced bowel obstruction, small bowel perforation secondary to the bowel obstruction, infection, fistula, sepsis, abscess, necrosis, inflammation, nerve damage, open wound with difficult healing, dense adhesions, loss of abdominal domain, significant soft tissue edema, bowel edema that prohibited primary closure by component separation, mesh migration, loss of muscle control, diagnosed with c difficile with increasing nausea and vomiting, recurrence, developed abdominal compartment syndrome with increasing hypotension, oliguria, distended abdomen, murky fluid from intraperitoneal cavity, and fibrinous exudate within abdomen. Post-operative treatment required included multiple exploratory laparotomies with lysis of adhesions, small bowel resection, primary small bowel anastomosis, multiple abdominal washouts, component separation and closure, abdominal debridement, multiple wound vac placements, placement of a right arterial line, right chest tube thoracostomy bowel resection, mesh removal/removal surgery, and wound closure surgery. Information received indicates the patient has deceased due to multiple organ failure. No information was provided regarding the association of the circumstances of expiration with this device.
 
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 ventral incisional hernia. It was reported that after a procedure where this device was implanted, the patient experienced small bowel perforation secondary to bowel obstruction, infection, fistula, sepsis, abscess, necrosis, inflammation, nerve damage, open wound with difficult healing, dense adhesions, loss of abdominal domain, significant soft tissue edema, bowel edema that prohibited primary closure by component separation, mesh migration, loss of muscle control, diagnosed with c difficile with increasing nausea and vomiting, recurrence, developed abdominal compartment syndrome with increasing hypotension, oliguria, distended abdomen, murky fluid from intraperitoneal cavity, injury, mental anguish, pain, abdominal pain, constipation, multiple organ failure, respiratory distress, failure of mesh, mesh erosion, dehiscence, damage, defective mesh, disability, disfigurement, loss in capacity to enjoy life, depression, psychological stress, fibrinous exudate within the abdomen, shortened life expectancy, and death. Post-operative treatment required included multiple exploratory laparotomies with lysis of adhesions, small bowel resection, primary small bowel anastomosis, multiple abdominal washouts, component separation and closure, abdominal debridement, multiple wound vac placements, placement of a right arterial line, right chest tube thoracostomy bowel resection, mesh removal/ removal surgery, hospitalization, and wound closure surgery. Information received indicates the patient has deceased due to multiple organ failure.
 
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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 Key7533448
MDR Text Key108891346
Report Number9615742-2018-01178
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050187
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup,Followup
Report Date 07/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPCO1510OS
Device Catalogue NumberPCO1510OS
Device Lot NumberPH600051
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/17/2021
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: 05/22/2018 Patient Sequence Number: 1
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