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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 PCO2015
Device Problems Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Cellulitis (1768); Purulent Discharge (1812); Edema (1820); Emotional Changes (1831); Erythema (1840); Fever (1858); Hematoma (1884); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Inflammation (1932); Muscle Weakness (1967); Necrosis (1971); Pain (1994); Scar Tissue (2060); Sepsis (2067); Tachycardia (2095); Thrombus (2101); Chills (2191); Discharge (2225); Hernia (2240); Injury (2348); Disability (2371); Impaired Healing (2378); Ascites (2596); Blood Loss (2597); Weight Changes (2607); Fluid Discharge (2686); No Code Available (3191); Thrombosis/Thrombus (4440); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); 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 hernia. It was reported that after implant, the patient experienced chronic pain, infection, recurrence, excision, revision.
 
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 an incisional hernia. It was reported that after implant, the patient experienced chronic pain, infection, recurrence, open wound, dense adhesions, extensive abscess formation, anterior intra-abdominal compartment with foci of gas indicating frank pus, (b)(6), inflammation, infection, phlegmon, cellulitis, colonic diverticulosis, serosanguineous discharge, fever, chills, weight loss, blanching erythema, edema, wound dehiscence, small blood clots, scar splitting open with drainage of pus and blood, tachycardia, hypotension, acute kidney injury, fluid collection, pelvic wall diastasis, sepsis, necrotic tissue, purulent material, leukocytosis, hematoma, permanently disabled, attenuated lower rectus abdominis fascia, mental pain, disability, impairment, loss of enjoyment of life, and defective mesh. Post-operative patient treatment included excision, revision, ventral explant implant, inguinal implant, abdominal wall closure with wound vac placement, vasopressors for normotension, washout of wound, antibiotics, drain removed, seroma catheter placed for drainage, excision of seroma capsule, lysis of adhesions, bilateral component separation, hospitalization in icu, and another ventral implant.
 
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 incisional hernia. It was reported that after implant, the patient experienced chronic pain, infection, recurrence, open wound, dense adhesions, extensive abscess formation, anterior intra-abdominal compartment with foci of gas indicating frank pus, (b)(6), inflammation, infection, phlegmon, cellulitis, colonic diverticulosis, serosanguineous discharge, fever, chills, weight loss, blanching erythema, edema, wound dehiscence, small blood clots, scar splitting open with drainage of pus and blood, tachycardia, hypotension, acute kidney injury, fluid collection, pelvic wall diastasis, sepsis, necrotic tissue, purulent material, leukocytosis, hematoma, permanently disabled, attenuated lower rectus abdominis fascia, and hospitalization in icu. Post-operative patient treatment included excision, revision, ventral explant implant, inguinal implant, abdominal wall closure with wound vac placement, vasopressors for normotension, washout of wound, antibiotics, drain removed, sermoa catheter placed for drainage, excision of seroma capsule, lysis of adhesions, bilateral component separation, and another ventral implant.
 
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 an incisional hernia. It was reported that after implant, the patient experienced chronic pain, infection, recurrence, open wound, dense adhesions, extensive abscess formation, anterior intra-abdominal compartment with foci of gas indicating frank pus, (b)(6), inflammation, infection, phlegmon, cellulitis, colonic diverticulosis, serosanguineous discharge, fever, chills, weight loss, blanching erythema, edema, wound dehiscence, small blood clots, scar splitting open with drainage of pus and blood, tachycardia, hypotension, acute kidney injury, and hospitalization in icu. Post-operative patient treatment included excision, revision, ventral explant implant, inguinal implant, wound vac and another ventral implant.
 
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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 Key7985151
MDR Text Key124352081
Report Number9615742-2018-02336
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 Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 02/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/30/2016
Device Model NumberPCO2015
Device Catalogue NumberPCO2015
Device Lot NumberPLH00355
Was Device Available for Evaluation? No
Date Manufacturer Received01/26/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/02/2011
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: 10/19/2018 Patient Sequence Number: 1
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