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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS VERSATEX MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number VTX1515MX3
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Muscle Weakness (1967); Necrosis (1971); Peritonitis (2252); Post Operative Wound Infection (2446); Bowel Perforation (2668); Unspecified Tissue Injury (4559)
Event Date 06/28/2021
Event Type  Death  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, it was noted the patient had previously undergone colectomy and ileus operation twice by surgery for intestinal perforation done by ileostomy. When closing the abdominal wall after vacuum-assisted closure (vac) and also 4 days after there was iatrogenic intestinal perforation with diffuse peritonitis, stomi, the monofilament mesh for reinforcement of the fascia was applied and suture was used. There was chronic wound infection that reappeared, which despite repeated antibiotic cures, vac and more reoperations did not rehabilitate. The patient was increasingly weakened and medical complications included death.
 
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Brand NameVERSATEX
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 Key13757432
MDR Text Key287112518
Report Number9615742-2022-00184
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10884521532649
UDI-Public10884521532649
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
K150091
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
Report Date 04/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberVTX1515MX3
Device Catalogue NumberVTX1515MX3
Device Lot NumberSVA0123X200
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/23/2022
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: 03/14/2022 Patient Sequence Number: 1
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