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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 F10246-1620P
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Seroma (2069); Post Operative Wound Infection (2446)
Event Date 02/10/2020
Event Type  Injury  
Manufacturer Narrative
This patient experienced a persistent infection, wound dehiscence, and related events leading to eventual device removal. As these events were first experienced superficially, is unlikely that the implanted device was the initiating cause of these events.
 
Event Description
A patient underwent ventral hernia repair with ovitex 1sp on (b)(6) 2018. The patient developed persistent infection and wound dehiscence with presence of seroma. Surgical intervention was conducted on (b)(6) 2020 including debridement of abdominal wall skin/sinus tract and removal of embedded repair material.
 
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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 Key12533761
MDR Text Key273371929
Report Number3010513348-2021-00004
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 09/27/2021,09/29/2021
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 Date08/31/2018
Device Model NumberF10246-1620P
Device Catalogue NumberF10246-1620P
Device Lot NumberERT-6I10
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 Date07/09/2018
Device Age18 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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