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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Radiation Exposure, Unintended (3164); Constipation (3274)
Event Date 04/03/2019
Event Type  Injury  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to the reporter, after a primary ventral hernia procedure, the patient was concerned about constipation. An x-ray was performed, which confirmed the constipation.

 
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Brand NamePARIETENE DS
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR 01600
Manufacturer (Section G)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR 01600
Manufacturer Contact
lisa hernandez
60 middletown ave.
north haven, CT 06473
2034925563
MDR Report Key8595812
MDR Text Key144576842
Report Number9615742-2019-01665
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 HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial
Report Date 05/09/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/09/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/31/2019
Device MODEL NumberPPDS12
Device Catalogue NumberPPDS12
Device LOT NumberRSG0070X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/18/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured07/31/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 05/09/2019 Patient Sequence Number: 1
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