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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 Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)
Patient Problems Hernia (2240); Prolapse (2475); No Known Impact Or Consequence To Patient (2692); No Code Available (3191); Unspecified Tissue Injury (4559)
Event Type  Injury  
Manufacturer Narrative
(b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, post-operative a robotic laparoscopic abdominal wall reconstruction procedure, a portion of the mesh along with patient tissue was explanted during repair of recurrent hernia. The mesh fractured was repaired to complete the case. There was no patient injury.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Evaluation summary: one device was received for evaluation. As no lot number was provided, a review of the device history record could not be performed. All process and test criteria are verified as complying with qa specifications for all product lots prior release to market. The visual examination of the provided sample shows that the sample was not returned in its original packaging and the part of the mesh returned was found completely adhered with human flesh. The sample returned was unfeasible. It was not possible to investigate more. The investigation concluded that the reported condition could not be confirmed. Based on our investigation and a complaint history review, the manufacture of the device is not suspected. There is no indication that there is a defective lot or that this event represents an emerging adverse quality trend. 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
justin ellis
8200 coral sea st ne
mounds view,mn, CT 55112
7635265677
MDR Report Key7685141
MDR Text Key113883053
Report Number9615742-2018-01563
Device Sequence Number1
Product Code FTL
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 Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 08/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberVTX5050M
Device Catalogue NumberVTX5050M
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/19/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/17/2022
Was Device Evaluated by Manufacturer? Yes
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: 07/13/2018 Patient Sequence Number: 1
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