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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 F10254-2020G
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Seroma (2069)
Event Date 11/29/2021
Event Type  Injury  
Event Description
It was reported that a patient experienced a persistent seroma after implantation of ovitex r to reinforce a diep flap donor site on (b)(6) 2021. The implanted material was partially removed on (b)(6) 2021.
 
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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 Key13001805
MDR Text Key282211187
Report Number3010513348-2021-00007
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation
Type of Report Initial
Report Date 12/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberF10254-2020G
Device Catalogue NumberF10254-2020G
Device Lot NumberERT-21A02
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/14/2021
Distributor Facility Aware Date11/29/2021
Device Age11 MO
Event Location Hospital
Date Report to Manufacturer11/29/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/14/2021 Patient Sequence Number: 1
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