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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PARIETENE DS; MESH, SURGICAL, POLYMERIC
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SOFRADIM PRODUCTION SAS PARIETENE DS; MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PPDS12
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Seroma (2069)
Date of Event 03/06/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, the patient experienced a small seroma following a ventral hernia repair procedure.It was stated that the patient is still recovering.
 
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Brand Name
PARIETENE DS
Common Device Name
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR  01600
MDR Report Key8702182
Report Number9615742-2019-02206
Device Sequence Number2354184
Product Code FTL
UDI-Device Identifier10884521553446
UDI-Public10884521553446
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
K163212
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 06/14/2019
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 Expiration Date04/30/2019
Device Model NumberPPDS12
Device Catalogue NumberPPDS12
Device Lot NumberRRK1387X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/22/2019
Initial Report FDA Received Date06/14/2019
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 Other;
Patient Age64 YR
Patient Weight97
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