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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 F10246-1620P
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Seroma (2069)
Event Date 10/02/2020
Event Type  Injury  
Manufacturer Narrative
Review of manufacturing records did not result in any indication of a device problem.
 
Event Description
A patient underwent ventral hernia repair with ovitex 1sp on (b)(6) 2018. The patient developed persistent infection and wound dehiscence with presence of seroma. Surgical intervention was conducted on (b)(6) 2020 including debridement of abdominal wall skin/sinus tract and removal of embedded repair material.
 
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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 Key12595175
MDR Text Key278759100
Report Number3007321028-2021-00013
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 distributor,health profession
Reporter Occupation
Type of Report Initial
Report Date 10/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/13/2018
Device Model NumberF10246-1620P
Device Catalogue NumberF10246-1620P
Device Lot NumberERT-6I10
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 Manufactured09/28/2016
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: 10/07/2021 Patient Sequence Number: 1
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