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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 Problems Difficult to Open or Close (2921); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Nausea (1970); Radiation Exposure, Unintended (3164); No Code Available (3191)
Event Date 03/04/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, post laparoscopic ventral hernia, the patient complained of right sided abdominal pain described as intermittent sharp and stabbing pain that radiated to back, with associated nausea, vomiting and inability to urinate. The patient had a ct scan of the abdomen as a diagnostic test. The results showed a 0. 3cm obstructing stone at the right ureterovesical junction with mild. Medication given included: flomax, norco, and zofran. The patient was also hydrated with 2 liters of intravenous fluid and the subject was referred to urology. Some symptoms may be related to post-operative side-effects after hernia repair procedure, though renal stone may be unrelated. The patient is currently recovering.
 
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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 Key8459890
MDR Text Key140165601
Report Number9615742-2019-00772
Device Sequence Number1
Product Code FTL
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 user facility
Reporter Occupation
Type of Report Initial
Report Date 03/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2019
Device Model NumberPPDS12
Device Catalogue NumberPPDS12
Device Lot NumberRRK1387X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/05/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/01/2018
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: 03/28/2019 Patient Sequence Number: 1
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