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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION LP PRGRP ANTMCL MSH10X15CM LT MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION LP PRGRP ANTMCL MSH10X15CM LT MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number LPG1510AL
Device Problem Hole In Material (1293)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
According to the reporter, the surgeon implanted the device on an unknown date in (b)(6) 2015. The patient developed a seroma. The surgeon re-operated on the patient and discovered a hole in the mesh. Additional information has been requested but not yet received.
 
Manufacturer Narrative
(b)(4). No sample was provided for investigation. The visual examination of the provided picture shows good integration of the visible piece of mesh except at the -hole- location. The knitting of the textile is visible through the tissue integration. The -hole- is located inside a textile pore. A lack of integration of this pore is highly suspected and could have been induced by seroma. Without the sample a detailed investigation could not be performed. 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 the finished product specifications for all released lots.
 
Event Description
Additional information received, indicated that the surgeon closed the hole with a single stitch and closed the patient with an open procedure. A 10mm trocar was used to place the mesh. The patient has since successfully recovered.
 
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Brand NameLP PRGRP ANTMCL MSH10X15CM LT
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION
116 avenue du formans
trevoux
FR
Manufacturer (Section G)
SOFRADIM PRODUCTION
116 avenue du formans
trevoux
FR
Manufacturer Contact
sharon murphy
60 middletown ave
north haven, CT 06473
2034925267
MDR Report Key5554684
MDR Text Key42071464
Report Number9615742-2016-00016
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142900
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberLPG1510AL
Device Catalogue NumberLPG1510AL
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 Received04/20/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/07/2016 Patient Sequence Number: 1
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