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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 TECT1510ADPR
Device Problems Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Atrial Fibrillation (1729); Erosion (1750); Granuloma (1876); Ischemia (1942); Nausea (1970); Necrosis (1971); Pain (1994); Tachycardia (2095); Vomiting (2144); Hernia (2240); Injury (2348); Obstruction/Occlusion (2422); Ascites (2596); Bowel Perforation (2668); No Code Available (3191); Unspecified Tissue Injury (4559)
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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 laparoscopic therapeutic treatment of an inguinal hernia. It was reported that after the implant, the patient experienced hardened mesh, mesh erosion, perforated bowel, recurrence, volvulus, ascites, adhesions, granuloma, abdominal pain, nausea, vomiting, tachycardia, atrial fibrillation, ischemic bowel, and necrotic bowel. Post-operative patient treatment included revision surgery, bowel resection, antrectomy of 180 cm of small bowel with side-to-side antiperistaltic anastomosis of jejunum to ascending colon, incidental appendectomy, transferred to the icu, and partial removal of mesh.
 
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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
tracy landers
5920 longbow drive
boulder,co, CT 80301
3035816943
MDR Report Key9929605
MDR Text Key186590205
Report Number9615742-2020-00806
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 12/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2020
Device Model NumberTECT1510ADPR
Device Catalogue NumberTECT1510ADPR
Device Lot NumberSPI0170X
Was Device Available for Evaluation? No
Date Manufacturer Received11/17/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/12/2015
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: 04/06/2020 Patient Sequence Number: 1
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