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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 TECT1510ADPL
Device Problems Product Quality Problem (1506); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Nausea (1970); Scarring (2061); Vomiting (2144); Hernia (2240); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of bilateral inguinal hernia. It was reported that in (b)(6) 2012, the patient experienced recurrence and underwent open right inguinal hernia repair with new mesh. In (b)(6) 2015, the patient experienced small bowel obstruction and underwent extensive lysis of adhesions. Treatment provided for these conditions in (b)(6) of 2018 include explant, extensive lysis of adhesions lasting approximately 3 hours, recurrent ventral incisional hernia repair with new mesh, complex closure of abdominal wall, and wound vac placement.
 
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Brand NamePARIETEX
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 Key8167830
MDR Text Key130460142
Report Number9615742-2018-02783
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K982532
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 08/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/30/2016
Device Model NumberTECT1510ADPL
Device Catalogue NumberTECT1510ADPL
Device Lot NumberSLH00095
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/15/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/17/2011
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: 12/16/2018 Patient Sequence Number: 1
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