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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 TEM1208GL
Device Problem Torn Material (3024)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/03/2017
Event Type  malfunction  
Manufacturer Narrative
Evaluation summary: post market vigilance led an evaluation of one device. The visual examination of the returned sample shows that the sample was not returned in its original packaging: only the commercial box and the ifu. A review of the device history record has been performed. This review confirmed that this lot of products was reviewed and released according to qa specifications. Especially the review of qc records related to the mechanical testing of the textile batches used for this lot confirms compliance to qa specifications. The mesh was placed in a plastic pouch. The mesh was not contaminated by blood. The dimensions of the mesh were found as expected. The mesh was found torn from the central pre-cut hole until 1 cm opposite edge of the flap. This type of damage would be consistent with high force being applied when opening the flap. The mesh seems to have been tear by the user. The mesh seems to have been cut by the user below the colored yarn marker. Excessive manipulation by the user is highly suspected. The root cause could not be determined. If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter: per additional information received the surgeon was preparing it with forceps before implanting when it tore. The mesh looked as usual, there was no problem noticed.
 
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: during an open inguinal hernia procedure, using the lichtenstein method, the mesh was torn while the surgeon applied it around the spermatic cord. There was no injury as a result of the event. To correct the condition the surgeon used another mesh. The current patient status is alive with no 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 Key6538371
MDR Text Key194060118
Report Number9615742-2017-05119
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10884521177680
UDI-Public10884521177680
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K081050
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 12/08/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2022
Device Model NumberTEM1208GL
Device Catalogue NumberTEM1208GL
Device Lot NumberSRA2494X
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/29/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/09/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/08/2017
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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