• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION PARIETEX PCOX SKIRT 20X15CM X1 MESH, SURGICAL, POLYMERIC

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SOFRADIM PRODUCTION PARIETEX PCOX SKIRT 20X15CM X1 MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCO2015OSX
Device Problem Hole In Material (1293)
Patient Problem Hernia (2240)
Event Date 03/12/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
The device was used to cover a defect for a patient who had a large part of his abdominal wall/rectus muscle excised for a recurrent urachal adenocarcinoma. The patient made a good recovery and went on to have chemotherapy. The device was laid as an inlay, the muscle was approximated, and there was an area of approximately 6cm diameter where there was no muscle or facia covering the device. The edges of the muscle were secured to the device.
 
Manufacturer Narrative
(b)(4). No sample was provided for investigation. The visual examination of the provided pictures reveals a hole in the mesh. However, it is neither possible to determine where the tear is located: seam, open-skirt or another part of the mesh. Without the sample a detailed investigation could not be performed. The incident description suggests that a bridging technique (inlay) has been performed. The product instructions for use (ifu), which accompanies each device, states that the edge of the reinforcement is to be from 2 to 5 centimeters over the edges of the orifice(s) according to the size of the defect and the size of the reinforcement. It also states that a bridging technique may induce excessive tension (including at the fixation points). It is recommended, in the ifu, that, in order to maintain the elasticity and the porosity of the reinforcement, the mesh should not be overly stretched when it is being put in place. This device is not intended for gynecological use, and off-label use may be suspected as the procedure that was performed was urological in nature. As no lot number was provided, a review of the device history record could not be performed. All process and test criteria are verified as complying with the finished product specifications for all released lots.
 
Event Description
Additional information indicated that the patient presented with a recurrence. The initial mesh was not removed during the reoperation. The patient is currently doing well.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePARIETEX PCOX SKIRT 20X15CM X1
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION
116 avenue du formans
trevoux
FR
Manufacturer (Section G)
SOFRADIM PRODUCTION
116 avenue du formans
trevoux
FR
Manufacturer Contact
sharon murphy
60 middletown ave
north haven, CT 06473
2034925267
MDR Report Key5495978
MDR Text Key40187472
Report Number9615742-2016-00009
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K110815
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/17/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/11/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPCO2015OSX
Device Catalogue NumberPCO2015OSX
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 Received03/29/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-