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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS PROGRIP MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number TEM1208GR
Device Problems Loss of or Failure to Bond (1068); 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 Abscess (1690); Adhesion(s) (1695); Erosion (1750); Hemorrhage/Bleeding (1888); Laceration(s) (1946); Internal Organ Perforation (1987); Pain (1994); Discharge (2225); Hernia (2240); Injury (2348); Ascites (2596); Blood Loss (2597); Fluid Discharge (2686); Unspecified Tissue Injury (4559)
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 laparoscopic therapeutic treatment of a ventral hernia. It was reported that after implant, the patient experienced recurrence, extensive adhesions, serosal tears, abscess in left lateral abdominal area, leakage, mesh that pulled away from fascial edges, and bleeding. Post-operative patient treatment included exploratory laparotomy, recurrent incisional hernia repair with new bard mesh, omentum and small bowel attached to the inferior aspect of the mesh were dissected, all segment of composite mesh extended to below the umbilicus at the midline was excised, placement of bard mesh, bowel was teased off of the mesh and the abdominal wall, repair of serosal tears, removal of previous mesh, placement of new covidien permacol mesh, drainage of intrabdominal abscess as well as three areas of small bowel required resection: part that had leaked, torn during lysis of adhesions, and was devascularized from tearing and having bleeding.
 
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Brand NamePROGRIP
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 Key8518541
MDR Text Key142074906
Report Number9615742-2019-01318
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K081050
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 01/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2013
Device Model NumberTEM1208GR
Device Catalogue NumberTEM1208GR
Device Lot NumberSIG00200
Was Device Available for Evaluation? No
Date Manufacturer Received01/12/2022
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: 04/16/2019 Patient Sequence Number: 1
Treatment
PCO2015, TEM1208GL
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