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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AROA BIOSURGERY OVITEX REINFORCED TISSUE MATRIX SURGICAL MESH

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AROA BIOSURGERY OVITEX REINFORCED TISSUE MATRIX SURGICAL MESH Back to Search Results
Model Number F10246-2020P
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Fistula (1862)
Event Date 03/25/2019
Event Type  Injury  
Manufacturer Narrative
It is likely that the fistula formed secondary to a surgical error in the initial procedure such as a small bowl perforation. This would lead to fistula formation, abscess, and gross inflammation accounting for the noted extensive adhesions. Given the short time frame between initial surgery and the events noted (approximately 1 month), it is highly unlikely that the device would have caused or contributed to these events. While it is unlikely that the device is the initiating cause of the abscess and fistula, its presence may have been a factor in the inflammatory response and subsequent removal.
 
Event Description
After ventral hernia repair with ovitex 1sp on (b)(6) 2019, a patient presented with general malaise and fever. She presented with an abdominal wall abscess and small bowel fistula on (b)(6) 2019 with surgery to resolve. A portion of the device was removed. Part of the device was adherent to the small bowel and remained in situ.
 
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Brand NameOVITEX REINFORCED TISSUE MATRIX
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
AROA BIOSURGERY
2 kingsford smith place
airport oaks
auckland, 2022
NZ 2022
MDR Report Key12533783
MDR Text Key273371829
Report Number3010513348-2021-00005
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 09/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2019
Device Model NumberF10246-2020P
Device Catalogue NumberF10246-2020P
Device Lot NumberERT-7J01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/27/2021
Distributor Facility Aware Date03/25/2019
Device Age17 MO
Event Location Hospital
Date Report to Manufacturer09/21/2021
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: 09/27/2021 Patient Sequence Number: 1
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