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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 F10246-1822P
Device Problem Insufficient Information (3190)
Patient Problem Hernia (2240)
Event Date 08/10/2021
Event Type  Injury  
Manufacturer Narrative
The hernia recurrence was noted at the patient's final follow-up visit (approximately 26 months post-op) in a post-market study. The patient was known to have diabetes and undergone at least one previous hernia repair, known risk factors for hernia recurrence.
 
Event Description
A patient enrolled in a post-market study was reported to have a hernia recurrence approximately 26 months after incisional/ventral hernia repair with ovitex 1sp.
 
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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
MDR Report Key12748897
MDR Text Key280067572
Report Number3007321028-2021-00023
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
K153632
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial
Report Date 11/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/29/2020
Device Model NumberF10246-1822P
Device Catalogue NumberF10246-1822P
Device Lot NumberERT-8C13
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/23/2018
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: 11/03/2021 Patient Sequence Number: 1
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