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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 Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
According to the reporter, during a bilateral inguinal hernia repair, a hole was detected in the mesh. The defect did not result in any adverse consequences. Additional information has been requested but not yet received.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
Reference number: (b)(4). A review of the device history record has been performed. This review confirmed that this lot of products was released according to quality specifications, specifically those related to the mechanical testing of the textile batch used for this lot. The visual examination of the returned sample showed that: the sample was not returned in its original packaging. Only an opened blister was returned with mesh. No patient label was returned with the sample; mesh dimensions were found as expected. The mesh does not appear to have been used within the patient; a 3 cm-hole is visible in the seam, 8 mm far from the stopping point. The seam yarn is broken at several locations: after the stopping point, 3 cm further and a part of free yarn is in the middle. The reported condition was confirmed by sample examination. The root cause of the hole in the seam is broken yarn. The root cause of the broken yarn could not be reliably determined. The report has been added to our database which is monitored for similar occurrences. Based on our investigation and a complaint history review, the manufacture of the device is not suspected. There is no indication that there is a defective lot or that this event represents an emerging adverse quality trend. No immediate action is required.
 
Manufacturer Narrative
(b)(4).
 
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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 Key5554601
MDR Text Key42087641
Report Number9615742-2016-00015
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,Followup,Followup
Report Date 03/16/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/07/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2018
Device Model NumberLPG1510AL
Device Catalogue NumberLPG1510AL
Device Lot NumberRPH0404X
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/25/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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