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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION PARIETEX PCOX RND 9CM X1 MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION PARIETEX PCOX RND 9CM X1 MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCO9X
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Weight Changes (2607)
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
According to the reporter: patient called customer service to report a complaint regarding the mesh. Stating the it has caused her pain, problems that have been ongoing for 3 months, and weight gain of about 30 lbs and will be going to the er.
 
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Brand NamePARIETEX PCOX RND 9CM 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 Key6183290
MDR Text Key62670796
Report Number9615742-2016-00205
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110815
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 12/05/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/16/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPCO9X
Device Catalogue NumberPCO9X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/05/2016
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?
Type of Device Usage Unkown

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