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U.S. Department of Health and Human Services

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

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AROA BIOSURGERY OVITEX REINFORCED TISSUE MATRIX SURGICAL MESH Back to Search Results
Model Number F10256-2020G
Device Problem 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 initiated study.
 
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Brand NameOVITEX REINFORCED TISSUE MATRIX
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
AROA BIOSURGERY
2 kingsford smith place
airport oaks, auckland 2022
NZ 2022
MDR Report Key13170992
MDR Text Key285075432
Report Number3010513348-2022-00002
Device Sequence Number1
Product Code FTM
UDI-Device Identifier09421904065345
UDI-Public09421904065345
Combination Product (y/n)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation
Type of Report Initial
Report Date 01/05/2021,01/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2022
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
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/05/2021
Distributor Facility Aware Date12/08/2021
Event Location Hospital
Date Report to Manufacturer12/09/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 01/05/2022 Patient Sequence Number: 1
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