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

Catalog Number	F10246-2530P
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	03/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This patient had undergone multiple previous surgeries (including hernia repair and mesh removal) and had multiple comorbidities that may have contributed to this event.A dhr review was completed and no non-conformances or anomalies were found that may have caused or contributed to this event.Tela bio (importer) is submitting this report on behalf of aroa biosurgery (manufacturer) via exemption number e2017045.
Event or Problem Description
A patient with a history that includes previous hernia repair and mesh infection with staphylococcus underwent surgery for a takedown of a colostomy and fistula, a coloproctostomy, and repair of a recurrent incisional hernia.On (b)(6) 2019 surgery including extensive lysis of adhesions, bilateral component separation and placement of an intraperitoneal ovitex 1s permanent was performed.Patient developed a hematoma that became infected and the infection extended to the implant.Cultures were positive for morganella, proteus, and (b)(6).On (b)(6) 2019, the laparotomy was re-opened to wash out the wound.Upon opening the fascia it was noted that the infection had extended to the mesh which was subsequently removed.Antibiotics were given, a wound vac applied and regular inspections and debridement performed as necessary.As of (b)(6) 2019, the patient's infection appeared "dramatically improved".

• 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: 8518093
• Report Number: 3007321028-2019-00003
• Device Sequence Number: 13856021
• Product Code: FTM
• UDI-Device Identifier: 09421904065727
• UDI-Public: 09421904065727
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K181935
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/16/2019
• Report Date (Section F): 03/29/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: F10246-2530P
• Device Lot Number: ERT-8H14
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/22/2019
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2019
• Initial Report FDA Received Date: 04/16/2019
• 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; Other
• Patient Age: 65 YR