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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AROA BIOSURGERY, LTD. OVITEX 2S PERMANENT REINFORCED BIOSCAFFOLD SURGICAL MESH

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AROA BIOSURGERY, LTD. OVITEX 2S PERMANENT REINFORCED BIOSCAFFOLD SURGICAL MESH Back to Search Results
Model Number 2S PERMANENT
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Respiratory Failure (2484)
Event Type  Death  
Event Description
It was reported that a male patient passed away following an emergency ventral hernia repair surgery performed on (b)(6) 2016. Prior to surgery on (b)(6) 2016, the physician performed a component separation which was unsuccessful in achieving primary closure. The defect was not repaired at that time and the patient was placed in the icu. Ovitex 2s permanent reinforced bioscaffold was used to bridge the defect in the ventral hernia repair surgery performed on (b)(6) 2016; there were no reported complications encountered during the surgical procedure. Approximately one week post-op, (b)(6) 2016, the physician's assistant reported that the patient was "doing well. The incision is healing and he is slowly recovering. " the patient passed away sometime between (b)(6) 2016; the exact date of death is unknown. The cause of death was reported as respiratory failure. There is no suspected association between the death and the use of the product.
 
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Brand NameOVITEX 2S PERMANENT REINFORCED BIOSCAFFOLD
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
AROA BIOSURGERY, LTD.
2 kingsford smith place
airport oaks auckland 2022
NZ 2022
MDR Report Key5978441
MDR Text Key55667230
Report Number3010513348-2016-00001
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 09/26/2016,08/29/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/26/2016
Is this an Adverse Event Report? Yes
Device Operator
Device Model Number2S PERMANENT
Device Catalogue NumberSEE ATTACHED FILE
Device Lot NumberSEE ATTACHED FILE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/26/2016
Distributor Facility Aware Date08/29/2016
Device Age6 MO
Event Location Hospital
Date Report to Manufacturer08/31/2016
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: 09/26/2016 Patient Sequence Number: 1
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