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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AROA BIOSURGERY OVITEX 2S PERMANENT REINFORCED BIOSCAFFOLD; SURGICAL MESH

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AROA BIOSURGERY 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  
Manufacturer Narrative
The cause of death was reported as respiratory failure.There is no suspected association between the death and the use of the product.A manufacturing review was performed and found no evidence of a manufacturing related cause for the event.Device not returned to the manufacturer.
 
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.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 Name
OVITEX 2S PERMANENT REINFORCED BIOSCAFFOLD
Type of Device
SURGICAL MESH
Manufacturer (Section D)
AROA BIOSURGERY
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
yasmin rai
2 kingsford smith place
airport oaks
auckland, 2022
NZ   2022
498693035
MDR Report Key5995600
MDR Text Key56341409
Report Number3007321028-2016-00001
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 distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 08/31/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator Physician
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
Initial Date Manufacturer Received 08/31/2016
Initial Date FDA Received10/03/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/25/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death;
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