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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
Model Number F10246-1012P
Device Problem Device Contamination with Body Fluid (2317)
Patient Problem Abscess (1690)
Event Date 05/20/2020
Event Type  Injury  
Manufacturer Narrative
Given the culture results, it is likely that the bacteria originated from both the ischemic bowel and the skin.
 
Event Description
Ovitex 1sp was used to robotically repair an umbilical hernia containing two bowel loops, one of which was incarcerated causing bowel obstruction and bowel ischemia.The device was introduced through the incision site.Approximately one week later, the wound became red and an abscess formed between the ovitex and the abdominal wall.The surgeon started antibiotics, incised the abscess and removed the device.Cultures were positive for e.Coli and streptococcus.
 
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Brand Name
OVITEX REINFORCED BIOSCAFFOLD
Type of Device
SURGICAL MESH
Manufacturer (Section D)
AROA BIOSURGERY
2 kingsford smith place
airport oaks
auckland, 2022
NZ  2022
MDR Report Key10148826
MDR Text Key195293166
Report Number3010513348-2020-00003
Device Sequence Number1
Product Code FTM
UDI-Device Identifier09421904065093
UDI-Public09421904065093
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 05/27/2020,06/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date12/31/2020
Device Model NumberF10246-1012P
Device Catalogue NumberF10246-1012P
Device Lot NumberERT-9A06
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date05/26/2020
Device Age16 MO
Event Location Hospital
Date Report to Manufacturer05/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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