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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AROA BIOSURGERY LTD. OVITEX REINFORCED TISSUE MATRIX SURGICAL MESH

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AROA BIOSURGERY LTD. OVITEX REINFORCED TISSUE MATRIX SURGICAL MESH Back to Search Results
Model Number F10256-2020G
Device Problems Off-Label Use (1494); Insufficient Information (3190)
Patient Problem Hernia (2240)
Event Type  Injury  
Event Description
A patient located outside of the united states underwent repair of an external pelvic organ prolapse with ovitex r. The patient experienced a recurrence of this external prolapse. This is one of two reports from the same investigator initated study.
 
Manufacturer Narrative
Ovitex devices are not indicated for pelvic organ prolapse procedures, thus the device was used in an off-label manner. No device problem was found from review of the dhr. The devices in ert-20f07 were produced as per established manufacturing procedures. All process specifications including package labelling requirements were met.
 
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Brand NameOVITEX REINFORCED TISSUE MATRIX
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
AROA BIOSURGERY LTD.
2 kingsford smith place
airport oaks, auckland 2022
NZ 2022
Manufacturer (Section G)
AROA BIOSURGERY LTD.
2 kingsford smith place
airport oaks, auckland 2022
NZ 2022
Manufacturer Contact
tina obrien
2 kingsford smith place
airport oaks, auckland 2022
NZ   2022
MDR Report Key13178951
MDR Text Key285691396
Report Number3007321028-2022-02721
Device Sequence Number1
Product Code FTM
UDI-Device Identifier09421904065345
UDI-Public09421904065345
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K130547
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Distributor
Reporter Occupation
Type of Report Initial
Report Date 01/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2021
Device Model NumberF10256-2020G
Device Catalogue NumberF10256-2020G
Device Lot NumberERT-20F07
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/15/2020
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: 01/06/2022 Patient Sequence Number: 1
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