Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 THR 20X15CM X1; NONE
  • 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 THR 20X15CM X1; NONE Back to Search Results
Catalog Number PCO2015FX
Device Problems Hole In Material (1293); Torn Material (3024)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 04/22/2014
Event Type  Injury  
Event Description
Pt had a hernia repaired.Whilst in recovery it was realized that the pt had an unrelated bleeding problem.When taken back to theatre, the surgeon discovered that the implant mesh (2hrs prior) had holes in the mesh from tearing.It's believed the stay sutures may have had too much tension on them or the mesh failed.Corrective action taken relevant to the care of the pt: the pt was taken back to theatre and the problem rectified.Pt outcome: pt proceeded to recovery.
 
Manufacturer Narrative
(b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PARIETEX PCOX THR 20X15CM X1
Type of Device
NONE
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
2034925670
MDR Report Key3807448
MDR Text Key19769204
Report Number9615742-2014-00161
Device Sequence Number1
Product Code OTN
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
Reporter Occupation Other
Type of Report Initial
Report Date 04/23/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberPCO2015FX
Device Lot NumberPOA0345X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/23/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage Unknown
Patient Sequence Number1
-
-