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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS DEXTILE MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number DXT1612AR
Device Problem Loss of or Failure to Bond (1068)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/07/2022
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, during a laparoscopic bilateral inguinal hernia repair procedure, while implanting the mesh, the mesh did not align properly with the anatomy of the patient because of the anatomical properties of the mesh. This caused the inferior portion of the mesh to not lay properly. The surgeon also stated that the mesh did not give enough medical coverage for the surgeon to feel comfortable leaving the mesh in place. The surgeon decided to use a different mesh to complete the case and resolve the issue. There was no patient injury.
 
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Brand NameDEXTILE
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 Key14215606
MDR Text Key290148646
Report Number9615742-2022-00371
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K192443
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/21/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDXT1612AR
Device Catalogue NumberDXT1612AR
Device Lot NumberSVF0517X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/20/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/10/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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