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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 F10248-2540P
Device Problem Insufficient Information (3190)
Patient Problem Seroma (2069)
Event Type  Injury  
Manufacturer Narrative
A dhr review was completed and no non-conformances or anomalies were found that may have caused or contributed to this event. As of the week of (b)(6) 2019 it has been reported that the patient has improved, though no clinical details were shared. Therefore, it is unknown whether the device caused or contributed to this event.
 
Event Description
Ovitex 2sp was used to repair a ventral hernia via a bridging repair in (b)(6) 2018. It was reported that after this repair that the wound and hernia have healed, but the patient developed persistent superficial drainage. The patient has been managed for approximately eight months post-op.
 
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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 Key8880129
MDR Text Key153967627
Report Number3010513348-2019-00001
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 07/17/2019,08/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2020
Device Catalogue NumberF10248-2540P
Device Lot NumberERT-8H09
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date07/15/2019
Device Age4 MO
Event Location Hospital
Date Report to Manufacturer07/17/2019
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: 08/09/2019 Patient Sequence Number: 1
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