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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 F10254-2020G
Device Problem Insufficient Information (3190)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Multiple attempts were made to contact the surgeon who performed the breast reconstruction and no information was received. It is unknown whether the device caused or contributed to this event or it was due to other factors such as other devices used, surgical technique, or other circumstances. The company continues to attempt to "retreieve" more information. (b)(4).
 
Event Description
A patient reported that she underwent bilateral breast reconstruction in which ovitex was utilized. She reported that sometime after the procedure that she believed that the mesh did not stay in place in one breast and the implant "almost literally fell out". The breast implant ended up being surgically removed.
 
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Brand NameOVITEX REINFORCED BIOSCAFFOLD
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
AROA BIOSURGERY
2 kingsfordsmith place
airport oaks
auckland 2022
NZ 2022
Manufacturer (Section G)
AROA BIOSURGERY
2 kingsford smith place
airport oaks
auckland, 2022
NZ 2022
Manufacturer Contact
john urtz
1 great valley parkway
suite 24
malvern, PA 19355
4843202884
MDR Report Key8190303
MDR Text Key131182966
Report Number3007321028-2018-00002
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
K153633
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial
Report Date 11/30/2018,12/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2019
Device Catalogue NumberF10254-2020G
Device Lot NumberERT-8C06
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Distributor Facility Aware Date11/29/2018
Device Age8 MO
Event Location Other
Date Report to Manufacturer11/30/2018
Date Manufacturer Received11/29/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/14/2018
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: 12/21/2018 Patient Sequence Number: 1
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