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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 F10246-2020P
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Fever (1858); Fistula (1862); Malaise (2359)
Event Date 03/25/2019
Event Type  Injury  
Manufacturer Narrative
Result of manufacturing investigation did not indicate any issue with the subject device.
 
Event Description
After ventral hernia repair with ovitex 1sp on (b)(6) 2019, a patient presented with general malaise and fever. She presented with an abdominal wall abscess and small bowel fistula on (b)(6) 2019 with surgery to resolve. A portion of the device was removed. Part of the device was adherent to the small bowel and remained in situ.
 
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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 o'brien
2 kingsford smith place
airport oaks, auckland 2022
NZ   2022
MDR Report Key12611838
MDR Text Key275883724
Report Number3007321028-2021-00014
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
Reporter Occupation
Type of Report Initial
Report Date 10/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2019
Device Model NumberF10246-2020P
Device Catalogue NumberF10246-2020P
Device Lot NumberERT-7J01
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 Received09/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/05/2017
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: 10/11/2021 Patient Sequence Number: 1
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