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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 TEC3030
Device Problems Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Hernia (2240); Injury (2348); Obstruction/Occlusion (2422); Respiratory Failure (2484); Ascites (2596); 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 a symptomatic ventral hernia. It was reported that after implant, the patient experienced recurrence, adhesions, small bowel obstruction, and abdominal pain. Laparoscopic lysis of adhesions on (b)(6) 2011 found bloody ascitic like fluid in abdominal cavity. An exploratory laparotomy on (b)(6) 2011 found previous umbilical mesh cut through to get into the abdominal cavity, marked dilated small loops of bowel, and appendix was crushed and excised. The patient remained intubated based on the massive amount of fluid loss, and preop expiratory wheezes, and was ventilator dependent, had respiratory failure, hypotension, tachycardia, and ileus as complications during admission. Post-operative patient treatment included (b)(6) 2011 revision surgery and (b)(6) 2012 mesh removal surgery.
 
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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, MA 06473
2034925563
MDR Report Key8348768
MDR Text Key136455439
Report Number9615742-2019-00338
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,other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/01/2013
Device Model NumberTEC3030
Device Catalogue NumberTEC3030
Device Lot NumberPIK00533
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/19/2019
Was Device Evaluated by Manufacturer? No Answer Provided
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: 02/18/2019 Patient Sequence Number: 1
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