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

Catalog Number	F10246-2540P
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	04/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is likely that the bile leak and infection caused the partial digestion of the implant.A dhr review was completed and no non-conformances or anomalies were found that may have caused or contributed to this event.
Event or Problem Description
A patient treated for a ventral hernia with ovitex 1s p on (b)(6) 2019 underwent a reoperation on (b)(6) 2019.During the reoperation, a bile leak and an infection were noted.The ovine portion of the ovitex mesh had been partially digested.The implant was removed; the wound was left open and treated with negative wound pressure therapy.

• 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: 8574797
• Report Number: 3007321028-2019-00005
• Device Sequence Number: 11295122
• Product Code: FTM
• UDI-Device Identifier: 09421904065734
• UDI-Public: 09421904065734
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/02/2019
• Report Date (Section F): 04/16/2019

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: 08/31/2020
• Device Catalogue Number: F10246-2540P
• Device Lot Number: ERT-8I06
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/05/2019
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/16/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 05/02/2019
• 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: 70 YR