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U.S. Department of Health and Human Services

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

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AROA BIOSURGERY LTD. OVITEX REINFORCED BIOSCAFFOLD SURIGAL MESH Back to Search Results
Model Number F10248-1620P
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Seroma (2069)
Event Date 09/12/2019
Event Type  Injury  
Manufacturer Narrative
Despite repeated attempts, no further information was obtained. In the absence of further information, it is unknown whether the device in any way caused or contributed to this event.
 
Event Description
A patient who underwent a bridging hernia repair with ovitex 2sp on (b)(6) 2019 presented with a seroma approximately two weeks after surgery. It is reported that the patient was re-admitted to the operating room and that the surgeon found that the implant had been partially resorbed or digested and that the synthetic portion remained behind. The remaining portions were explanted.
 
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Brand NameOVITEX REINFORCED BIOSCAFFOLD
Type of DeviceSURIGAL MESH
Manufacturer (Section D)
AROA BIOSURGERY LTD.
2 kingsford smith place
airport oaks, 2022
NZ 2022
Manufacturer (Section G)
AROA BIOSURGERY LTD.
2 kingsford smith place
airport oaks, 2022
NZ 2022
Manufacturer Contact
tina obrien
2 kingsford smith place
airport oaks, auckland 2022
NZ   2022
MDR Report Key9183911
MDR Text Key164869016
Report Number3007321028-2019-00015
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 10/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2019
Is this an Adverse Event Report? Yes
Device Operator
Device Expiration Date01/31/2020
Device Model NumberF10248-1620P
Device Catalogue NumberF10248-1620P
Device Lot NumberERT-8B03
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 Received09/20/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/08/2018
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: 10/14/2019 Patient Sequence Number: 1
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