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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION PARIETEX PRO GRIP MESH

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SOFRADIM PRODUCTION PARIETEX PRO GRIP MESH Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Pain (1994); Swelling (2091)
Event Date 05/08/2009
Event Type  Injury  
Event Description

Procedure type: bilateral lap inguinal hernia repair. According to the reporter: the mesh gave away causing swelling in left groin, passing urine and other medical complications. The next surgery was done in 2011 which left me with swelling in the left scrotum, fluid build up, pain every day. Present mesh is a different mesh.

 
Manufacturer Narrative

(b)(4).

 
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Brand NamePARIETEX PRO GRIP MESH
Type of DevicePARIETEX PRO GRIP MESH
Manufacturer (Section D)
SOFRADIM PRODUCTION
116 avenue du formans
trevoux F-01 600
FR F-01600
Manufacturer (Section G)
SOFRADIM PRODUCTION
116 avenue du formans
trevoux F-01 600
FR F-01600
Manufacturer Contact
melissa zaffin
60 middletown ave.
north haven, CT 06473
2034927141
MDR Report Key2715719
MDR Text Key2797490
Report Number9615742-2012-00390
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 Consumer
Reporter Occupation PATIENT
Type of Report Initial
Report Date 07/23/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/21/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received07/23/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 08/21/2012 Patient Sequence Number: 1
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