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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 TEM1208GR
Device Problem Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/09/2017
Event Type  malfunction  
Manufacturer Narrative
The visual examination of the sample shows that the sample was placed in a biohazard bag. The mesh was contaminated by blood. The shape of the mesh was modified by some cut around the mesh and the mesh was torn just under the blue yarn marker (less than 2 stitches). The reported condition was confirmed. Excessive manipulation by the user is highly suspected. A review of the device history records has been performed. This review confirmed that this lot of products was reviewed and released according to qa specification. If information is provided in the future, a supplemental report will be issued.
 
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.
 
Event Description
According to the reporter: procedure: open right inguinal hernia repair. The mesh out of the package showed no imperfections. The mesh tore during preparation prior to implant. The doctor trimmed the peripheral aspects of the mesh so it would cover the area he desired. He passed the suture through the mesh and then he took one bite through the tissue overlying the pubic tubercle and then passed the needle end of the suture through the mesh just medial to the blue stitch on the mesh. The surgeon then tied the suture knots to secure the mesh. It was at that time the mesh tore and the suture released from the mesh due to the strands of mesh tearing. The surgeon indicated that he included several of the strands of the mesh when he started the knot tying but the mesh tore and the suture released from the mesh. The surgeon opened another piece of the mesh and successfully implanted it without further incident. This reported issue was detected in the operating room after opening the package. The mesh appearance was normal. The tamper-evident seal on the box was not peeled or damaged. To complete the case, another was opened and used. There was no injury to the patient. The surgical time was not extended.
 
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 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 ave
north haven, CT 06473
2034925267
MDR Report Key6689558
MDR Text Key194237503
Report Number9615742-2017-05179
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K081050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/28/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/06/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2021
Device Model NumberTEM1208GR
Device Catalogue NumberTEM1208GR
Device Lot NumberSQJ1017X
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/18/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/31/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/16/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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