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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 UNKNOWN PARIETEX
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Torn Material (3024); Material Split, Cut or Torn (4008)
Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Necrosis (1971); Pain (1994); Tissue Damage (2104); Vomiting (2144); Chills (2191); Hernia (2240); Discomfort (2330); Injury (2348); Weight Changes (2607); No Code Available (3191)
Event Date 03/17/2017
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
(b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Per additional information received, surgery performed to repair recurrent hernia. Adhesions were found from mesh to loops of small intestines. They attempted to remove the remainder of the mesh, but were unable to do so without causing extensive damage to intestines.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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. Product was used for therapeutic treatment of a hernia. After implant, it was reported that the patient experienced suffered life-threatening complications from the structural failure of the implant and approximately ten centimeters of the patient's small intestine needed to be surgically removed. The patient also experienced pain, abdominal wall discomfort, abdominal pain, bouts of emesis, chills, weight gain, incarcerated hernia, bulge, inability to eat due to nausea, soft mass palpated which cannot be fully reduced, diastasis, multiple ventral hernias, and torn mesh. The patient required additional surgery (b)(6) 2017 to repair the recurrent hernia. During the repair dense adhesions of bowel/omentum to the underside of the hernia sac mesh were found, where several loops of small bowel were incarcerated. Because of the large hernia and prior resection of mesh/rectus muscle, there was a loss of abdominal domain. Mesh removal was attempted but could not be completed without causing extensive damage to intestines.
 
Manufacturer Narrative
Manufacturer reference number: (b)(4). Patient information not provided. Lot number not provided. Udi not provided. Re-processing information not provided. Since the lot number was not provided, this information cannot be determined. (b)(4).
 
Event Description
The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome. Product was used for therapeutic treatment. A mesh device that was implanted in the patient's abdomen ripped apart. The patient suffered life-threatening complications from the structural failure of the implant and approximately ten centimeters of the patient's small intestine needed to be surgically removed. The patient is now in constant pain and has suffered a permanent reduction in her quality of life.
 
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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 Key6610584
MDR Text Key109408421
Report Number9615742-2017-05152
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 01/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN PARIETEX
Device Catalogue NumberUNKNOWN PARIETEX
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/05/2018
Was Device Evaluated by Manufacturer? No
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: 06/05/2017 Patient Sequence Number: 1
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