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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PARIETEX; MESH, SURGICAL, POLYMERIC
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SOFRADIM PRODUCTION SAS PARIETEX; MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCOPM20
Medical Device Problem Code Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes Hernia (2240); No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event 05/01/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, during laparoscopic parastomal hernia procedure, when re operating recurrence, the device was broken in the seem.Re-operation was done to resolve the issue.
 
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Brand Name
PARIETEX
Common Device Name
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR  01600
MDR Report Key8131301
Report Number9615742-2018-02656
Device Sequence Number13520140
Product Code FTL
UDI-Device Identifier10884521177789
UDI-Public10884521177789
Combination Product (Y/N)N
Initial Reporter CountryNO
PMA/510(K) Number
K081126
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 12/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberPCOPM20
Device Catalogue NumberPCOPM20
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/08/2018
Initial Report FDA Received Date12/04/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age32 YR
Patient Weight74
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