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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION PARIETEX PCOX RND 12CM X1 MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION PARIETEX PCOX RND 12CM X1 MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCO12X
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/16/2015
Event Type  Malfunction  
Event Description

According to the reporter: during a hernia procedure the product did not lay flat on the patient. It would curl up and it was not straight. Another product was used. There was no patient injury.

 
Manufacturer Narrative

Manufacturer reference number (b)(4) filed under 9615742-2016-00157 was confirmed to be a duplicate of a previously reported event under manufacturer reference number (b)(4), mdr report number 9615742-2015-00043. File (b)(4) will be voided as a duplicate entry.

 
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Brand NamePARIETEX PCOX RND 12CM 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 avenue
north haven, CT 06473
2034925267
MDR Report Key6087549
MDR Text Key59465248
Report Number9615742-2016-00157
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
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 10/13/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/08/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPCO12X
Device Catalogue NumberPCO12X
Device LOT NumberPOE0511X
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 Received10/13/2016
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

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