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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION UNKNOWN PARIETEX PRODUCT; SOFRADIM MESH
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SOFRADIM PRODUCTION UNKNOWN PARIETEX PRODUCT; SOFRADIM MESH Back to Search Results
Catalog Number UNKNOWN PARIETEX
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Hernia (2240); Therapeutic Response, Decreased (2271)
Event Type  Injury  
Event Description
Procedure type: laparoscopic incisional hernia repair.According to the reporter: in an article titled "central failure of lightweight monofilament polyester mesh causing hernia recurrence: a cautionary note" by petro, c.C.Et al, that appeared in hernia, doi 10.1007/s10029-014-1237-5, published online 23 march 2014, the authors report that from a study of 36 patients undergoing incisional hernia repair with parietex tcm, there were 8 recurrences which required reoperation.This complaint is for one of those recurrences.
 
Manufacturer Narrative
(b)(4).
 
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Brand Name
UNKNOWN PARIETEX PRODUCT
Type of Device
SOFRADIM 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
sharon murphy, qa
60 middletown ave
north haven, CT 06473
2034925267
MDR Report Key3775850
MDR Text Key4358222
Report Number9615742-2014-00134
Device Sequence Number1
Product Code OTP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature,Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 03/21/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKNOWN PARIETEX
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/21/2014
Initial Date FDA Received04/21/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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