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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ PROGRIP¿ MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ PROGRIP¿ MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number TEM3015G
Device Problem Torn Material (3024)
Patient Problem No Code Available (3191)
Event Date 12/01/2015
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-operatively, the patient came back after one and half years after the surgery of ventral hernia in sublay technique because there was a recurrence of mesh ripped/torn. A surgical intervention was needed another surgery was necessary to repair his abdominal wall, he extended his stay in the hospital for 3 to 4 days more. The original mesh was not removed. The fascia was closed again and another mesh was placed on top and fixed with sutures. There will be an additional operation performed to correct the issue. The appearance of the mesh was white; dry, polyester + polylactide.
 
Event Description
According to the reporter, approximately a year and a half post-op, after a ventral hernia repair procedure, there was a recurrence of torn mesh. Another surgery was needed to repair the abdominal wall. Patient was discharged from the hospital after 4 days. The appearance of the mesh was white; dry, polyester and polylactid. The patient status is alive with a temporary injury.
 
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Brand NameMESH SOFRADIM - PARIETEX¿ PROGRIP¿
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
sharon murphy
60 middletown avenue
north haven, CT 06473
2034925267
MDR Report Key6761005
MDR Text Key109544092
Report Number9615742-2017-05196
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/31/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2020
Device Model NumberTEM3015G
Device Catalogue NumberTEM3015G
Device Lot NumberSPJ0231X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/31/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/28/2015
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: 08/02/2017 Patient Sequence Number: 1
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