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

MAUDE Adverse Event Report: ASPIDE MEDICAL SURGIMESH XB TINTRA OK-1522

  • 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
 

ASPIDE MEDICAL SURGIMESH XB TINTRA OK-1522 Back to Search Results
Model Number TINTRA OK-1522
Device Problem Device Slipped (1584)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 12/29/2015
Event Type  Injury  
Event Description
Patient had a recurrent 3-defect ventral hernia repaired with a xb ok-1522 on (b)(6) 2013 that was the result of two prior c-sections. The surgeon agreed to repair the hernia as the patient stated that they planned no more pregnancies. The patient subsequently became pregnant and had another c-section. The patient experienced a recurrence in the area of the prior hernia repair with the xb ok-1522. On (b)(6) 2015 the patient returned to have the previously placed xb ok-1522 mesh explanted. The hernia defect was repaired using a new piece of xb ok-1522. The patient recovered uneventfully.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSURGIMESH XB
Type of DeviceTINTRA OK-1522
Manufacturer (Section D)
ASPIDE MEDICAL
246 allee lavoisier
latalaudiere 42350 FR
FR 42350 FR
Manufacturer (Section G)
BG MEDICAL LLC
20925 pheasant trail
suite 100
deer park IL 60010
Manufacturer Contact
20925 pheasant trail
suite 100
deer park, IL 60010
MDR Report Key5427431
MDR Text Key37959635
Report Number3005841068-2016-00001
Device Sequence Number1
Product Code FTL
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Nurse
Type of Report Initial
Report Date 02/03/2016,01/29/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2014
Device Model NumberTINTRA OK-1522
Device Catalogue NumberTINTRA OK-1522
Device Lot NumberF07444A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/03/2016
Distributor Facility Aware Date01/04/2016
Device Age28 MO
Event Location Hospital
Date Report to Manufacturer02/03/2016
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/02/2016 Patient Sequence Number: 1
-
-