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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
Catalog Number F10248-1620P
Device Problem Insufficient Information (3190)
Patient Problem Seroma (2069)
Event Date 09/12/2019
Event Type  Injury  
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 or 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 DeviceSURGICAL MESH
Manufacturer (Section D)
AROA BIOSURGERY
2 kingsford smith place
airport oaks
auckland, 2022
NZ 2022
MDR Report Key9181893
MDR Text Key162295858
Report Number3010513348-2019-00005
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 10/11/2019,09/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2020
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? Yes
Date Report Sent to FDA10/11/2019
Distributor Facility Aware Date09/16/2019
Device Age7 MO
Event Location Hospital
Date Report to Manufacturer09/19/2019
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: 10/11/2019 Patient Sequence Number: 1
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