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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 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  
Manufacturer Narrative
No device problem was found from review of the dhr. The devices in the subject lot were produced as per established manufacturing procedures. All process specifications including package labelling requirements were met.
 
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 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 Key13003967
MDR Text Key285170381
Report Number3007321028-2021-00025
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153633
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Distributor
Reporter Occupation
Type of Report Initial
Report Date 12/15/2021
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
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/06/2021
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: 12/14/2021 Patient Sequence Number: 1
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