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U.S. Department of Health and Human Services

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

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AROA BIOSURGERY LTD. OVITEX REINFORCED BIOSCAFFOLD SURGICAL MESH Back to Search Results
Model Number F10244-1020P
Device Problem Insufficient Information (3190)
Patient Problem Pain (1994)
Event Date 06/04/2020
Event Type  Injury  
Manufacturer Narrative
No device problem was found from review of the dhr. The devices in ert-8f03 were produced as per established manufacturing procedures. All process specifications were met.
 
Event Description
It was reported that a patient experienced a potential "reaction" to an ovitex p mesh implanted on (b)(6) 2019. It was removed on (b)(6) 2020.
 
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Brand NameOVITEX REINFORCED BIOSCAFFOLD
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 Key10192611
MDR Text Key199471199
Report Number3007321028-2020-00008
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153632
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 06/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2020
Device Model NumberF10244-1020P
Device Catalogue NumberF10244-1020P
Device Lot NumberERT-8F03
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/12/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/06/2018
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: 06/24/2020 Patient Sequence Number: 1
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