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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 TET3030
Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Wound Dehiscence (1154); Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Erosion (1750); Purulent Discharge (1812); Foreign Body Reaction (1868); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Staphylococcus Aureus (2058); Scar Tissue (2060); Discharge (2225); Excessive Tear Production (2235); Hernia (2240); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Ascites (2596); Abdominal Distention (2601); Fibrosis (3167); No Code Available (3191)
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 an incarcerated umbilical hernia. It was reported that after implant, the patient experienced recurrence, numerous adhesions, old mesh incorporated some of scar tissue, subacute fascial wound dehiscence with exposed viscera, right edge of mesh had pulled off of fascia and exposed bowel and mesentery at periumbilical wound, dense abdominal wall adhesions where the bowel had subacutely eviscerated, dense intraabdominal adhesions, serosal tears, mesh had odor and foul-smelling, bowel leak from a distal jejunal enterotomy with significant succus in abdomen, old incorporated mesh that was seeding the sinus tract, infection, ascites, abscess, and purulent discharge. Post-operative patient treatment included recurrent incarcerated incisional hernia repair with mesh, incarcerated omentum was reduced, excised bulk of the old mesh, removal of old infected mesh, incarcerated tissue was reduced, extensive lysis of adhesions required to free anterior abdominal wall and mobilize small bowel off surgical site and mesh, repair to serosal tears, segmental small bowel resection, debridement of anterior abdominal wall, excision of intraperitoneal and anterior abdominal wall mesh, vac dressing applied, abdominal washout, abdominal wall closure with mesh, abdominal re-exploration for postoperative sepsis, evacuated turbid fluid sitting in central lower abdomen, incision and drainage of right retroperitoneal abscess as well as thick, tan, purulent fluid was obtained and lastly, ventral/incisional hernia repair with 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
lisa hernandez
60 middletown ave
north haven, CT 06473
2034925563
MDR Report Key8765211
MDR Text Key150171588
Report Number9615742-2019-02425
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K982532
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
Report Date 02/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2012
Device Model NumberTET3030
Device Catalogue NumberTET3030
Device Lot NumberSHL00395
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/05/2019
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: 07/05/2019 Patient Sequence Number: 1
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