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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 Consequences Or Impact To Patient (2199)
Event Date 04/16/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
According to the reporter, the mesh had a tear/ hole in it upon removing it from the packaging. There was no impact to the patient.
 
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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 Key5797899
MDR Text Key49636553
Report Number9615742-2016-00092
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143386
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 07/13/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberLPG1510AL
Device Catalogue NumberLPG1510AL
Device Lot NumberRPH0404X
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/13/2016
Was Device Evaluated by Manufacturer? No Answer Provided
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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