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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 PCOPM15
Device Problem Material Split, Cut or Torn (4008)
Patient Problems Adhesion(s) (1695); Pain (1994); Tissue Damage (2104); Hernia (2240); Fibrosis (3167); No Code Available (3191)
Event Date 02/06/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, during a laparoscopic hernia procedure, only the sides of the mesh was left. The midline of the mesh was gone and the intestines had adhere to it. Re surgery was done to repair the hernia recurrence and to free the adhesions. There was tissue damage of adhesions and fibrotic tissue. The patient was hospitalized. The surgical time was extended by three to five hours. The patient had to undergo surgery after this operation also because of pain occurring because of adhesions once again.
 
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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 Key8447973
MDR Text Key139696651
Report Number9615742-2019-00636
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeNO
PMA/PMN Number
K081126
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPCOPM15
Device Catalogue NumberPCOPM15
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/01/2019
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: 03/25/2019 Patient Sequence Number: 1
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