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U.S. Department of Health and Human Services

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

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AROA BIOSURGERY 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  
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
2 kingsford smith place
airport oaks
auckland, 2022
NZ 2022
MDR Report Key10189578
MDR Text Key196253418
Report Number3010513348-2020-00004
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 06/24/2020
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? Yes
Date Report Sent to FDA06/24/2020
Distributor Facility Aware Date06/05/2020
Device Age1 YR
Event Location Hospital
Date Report to Manufacturer06/11/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/24/2020 Patient Sequence Number: 1
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