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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 VTX5050M
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)
Patient Problems Hernia (2240); Unspecified Tissue Injury (4559)
Event Date 03/06/2017
Event Type  Injury  
Manufacturer Narrative
Medtronic complaint number: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Per additional information received the defect was repaired robotically, tear in mesh was closed with prolene suture. The mesh was not removed. No mesh was used due to gallbladder removal at same time.
 
Manufacturer Narrative
(b)(4).
 
Event Description
According to reporter when the patient fell off an exam table at another doctors office they felt a pop, resulting in recurrence. The recurrence was later fixed robotically. The issue was post op, resulting in another repair of the recurrence. The original surgical procedure was an open repair of ventral incisional hernia and abdominal wall reconstruction and cholecystectomy. The size of the defect was 21m x 30cm. The location of the hernia is midline. The fixation system used was suture. The mesh was cut prior to implantation. The appearance of the mesh was normal. The patent outcome is alive - no injury.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
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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, CT 80301
3035816943
MDR Report Key6649870
MDR Text Key106299102
Report Number9615742-2017-05163
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10884521532298
UDI-Public10884521532298
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150091
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 07/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2020
Device Model NumberVTX5050M
Device Catalogue NumberVTX5050M
Device Lot NumberSPJ1016X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received07/08/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/19/2015
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: 06/19/2017 Patient Sequence Number: 1
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