MAUDE Adverse Event Report: AROA BIOSURGERY OVITEX REINFORCED BIOSCAFFOLD; SURGICAL MESH

Model Number	F10246-1012P
Medical Device Problem Code	Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	Abscess (1690)
Date of Event	05/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Given the culture results, it is likely that the bacteria originated from both the ischemic bowel and the skin.
Event or Problem 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.

• Brand Name: OVITEX REINFORCED BIOSCAFFOLD
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): AROA BIOSURGERY; 2 kingsford smith place; airport oaks; auckland, 2022 ; NZ 2022
• MDR Report Key: 10148826
• Report Number: 3010513348-2020-00003
• Device Sequence Number: 2318822
• Product Code: FTM
• UDI-Device Identifier: 09421904065093
• UDI-Public: 09421904065093
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/12/2020
• Report Date (Section F): 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: F10246-1012P
• Device Catalogue Number: F10246-1012P
• Device Lot Number: ERT-9A06
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/26/2020
• Device Age: 16 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/27/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention