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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 DXT1309AR
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Hernia (2240); Swelling/ Edema (4577); Insufficient Information (4580)
Event Date 01/26/2022
Event Type  Injury  
Event Description
According to the reporter, postoperative to totally extraperitoneal inguinal hernia repair, the patient had a swollen groin on the same side of the procedure (right). The patient had inguinal hernia recurrence.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 Key14145445
MDR Text Key289616730
Report Number9615742-2022-00331
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10884521726499
UDI-Public10884521726499
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K192443
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 07/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDXT1309AR
Device Catalogue NumberDXT1309AR
Device Lot NumberSUL1336X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/23/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/23/2020
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: 04/19/2022 Patient Sequence Number: 1
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