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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 PPDS2015
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Vomiting (2144); Unintended Radiation Exposure (4565); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 08/06/2019
Event Type  Injury  
Event Description
According to the reporter, following a ventral hernia repair, the patient experienced post- operative emesis on liquid diet, inability to tolerate liquid diet. Computerized tomography (ct) scan was ordered and revealed slight ileus. The ileus occurred 7 days after the procedure. No obvious cause present on ct scan. Patient improved following esophagogastroduodenoscopy (egd) with dilation performed for treatment of esophageal stricture. The patient was hospitalized for 12 days.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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
tracy landers
5920 longbow drive
boulder, CO 80301
3035816943
MDR Report Key14283910
MDR Text Key290793744
Report Number9615742-2022-00427
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10884521553477
UDI-Public10884521553477
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K163212
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2021
Device Model NumberPPDS2015
Device Catalogue NumberPPDS2015
Device Lot NumberETB1824X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/22/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/05/2019
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: 05/04/2022 Patient Sequence Number: 1
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