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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PERMACOL MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION SAS PERMACOL MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 5240-150
Device Problem Degraded (1153)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/31/2017
Event Type  malfunction  
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: occurred during an open incisional hernia repair. The mesh was damaged which caused it to disintegrate in the middle. The surgeon did not manage to close the defect and placed a vac system over the mesh. Patient status 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 NamePERMACOL
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
2034915267
MDR Report Key6681602
MDR Text Key78913256
Report Number9615742-2017-05177
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeSF
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 06/01/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/30/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2021
Device Model Number5240-150
Device Catalogue Number5240-150
Device Lot NumberAQC0512
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 Received06/01/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/16/2016
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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