• 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 PROGRIP 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 PROGRIP MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number TEM1409GL
Device Problems Material Integrity Problem (2978); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Emotional Changes (1831); Pain (1994); Hernia (2240); Unspecified Tissue Injury (4559)
Event Type  Injury  
Event Description
The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of a hernia. It was reported that after implant, the patient experienced mesh failed, mesh shrinkage, recurrence, adhesions, defective device, mental and physical pain, suffering, disability, impairment, and loss of enjoyment of life. Post-operative patient treatment included small bowel resection and mesh removal surgery.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 80301
3035816943
MDR Report Key12950333
MDR Text Key281834936
Report Number9615742-2021-02451
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10884521177703
UDI-Public10884521177703
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
Report Date 12/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTEM1409GL
Device Catalogue NumberTEM1409GL
Device Lot NumberSSG0830X
Was Device Available for Evaluation? No
Date Manufacturer Received11/17/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/24/2018
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: 12/07/2021 Patient Sequence Number: 1
Treatment
TEM1409GR SSF1355X
-
-