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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 F10246-1822P
Device Problem Insufficient Information (3190)
Patient Problem Hernia (2240)
Event Date 08/10/2021
Event Type  Injury  
Manufacturer Narrative
The hernia recurrence was noted at the patient's final follow-up visit (approximately 26 months post-op) in a post-market study.The patient was known to have diabetes and undergone at least one previous hernia repair, known risk factors for hernia recurrence.
 
Event Description
A patient enrolled in a post-market study was reported to have a hernia recurrence approximately 26 months after incisional/ventral hernia repair with ovitex 1sp.
 
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Brand Name
OVITEX REINFORCED TISSUE MATRIX
Type of Device
SURGICAL MESH
Manufacturer (Section D)
AROA BIOSURGERY
2 kingsford smith place
airport oaks, auckland 2022
NZ  2022
MDR Report Key12750743
MDR Text Key280075813
Report Number3010513348-2021-00006
Device Sequence Number1
Product Code FTM
UDI-Device Identifier09421904065123
UDI-Public09421904065123
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial
Report Date 11/04/2021,11/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/29/2020
Device Model NumberF10246-1822P
Device Catalogue NumberF10246-1822P
Device Lot NumberERT-8C13
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/04/2021
Distributor Facility Aware Date10/05/2021
Device Age28 MO
Event Location Hospital
Date Report to Manufacturer10/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age71 YR
Patient Weight82
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