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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION PARIETEX RIGID PY 15X15CM X1 MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION PARIETEX RIGID PY 15X15CM X1 MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number TECR1515
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Injury (2348)
Event Date 06/14/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). (b)(6).
 
Event Description
Procedure: lap inguinal hernia repair. (b)(6) 2016. According to the reporter: procedure date: doctor implanted tecr1515 in the patient on (b)(6) 2014 in a laparoscopic bilateral inguinal hernia repair. The patient came back with an infection in 2015 on one side and came back in 2016 with an infection on the other side. All cultures have come back negative. The mesh was removed. The following 2 surgery dates to remove the mesh are unknown.
 
Manufacturer Narrative
Lot # unknown.
 
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Brand NamePARIETEX RIGID PY 15X15CM X1
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
MDR Report Key6183400
MDR Text Key62670625
Report Number9615742-2016-00206
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K982532
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/05/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberTECR1515
Device Catalogue NumberTECR1515
Device Lot NumberSNJ0013X
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 Received01/12/2017
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: 12/16/2016 Patient Sequence Number: 1
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