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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION PARIETEX PG RECT 30X15CM
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SOFRADIM PRODUCTION PARIETEX PG RECT 30X15CM Back to Search Results
Model Number TEM3015G
Device Problem Material Disintegration (1177)
Patient Problems Hernia (2240); Therapeutic Response, Decreased (2271)
Event Date 12/11/2014
Event Type  No Answer Provided  
Event Description
Procedure: cicatrice hernia in open sublay technique.The tem3015g was inserted into patient about one year ago.Dr.(b)(6) operated the patient again cause of a cicatrice hernia.At this re-operation dr.(b)(6) found only little net-residuals.Therefore, he assumed that the relapse came from the dissolving of the net.But he cannot understand this phenomen.Surgical report and lot no.Is asked from the sales rep and will be send asap.No blood loss, no extension of op, no loss or damage to tissue, no reinforcement material used.
 
Manufacturer Narrative
(b)(4).
 
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Brand Name
PARIETEX PG RECT 30X15CM
Type of Device
PARIETEX PG
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 Key4346254
MDR Text Key21171925
Report Number9615742-2014-00349
Device Sequence Number1
Product Code OTP
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Invalid Data
Reporter Occupation Other
Type of Report Initial
Report Date 12/12/2014
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? No
Device Operator Other
Device Model NumberTEM3015G
Device Catalogue NumberTEM3015G
Device Lot NumberNOT AVAILABLE
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/12/2014
Initial Date FDA Received12/19/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Patient Sequence Number1
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