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

Catalog Number	F10248-1822P
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Abscess (1690)
Date of Event	05/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Despite repeated requests, no further details on the cause, location, or content of the abscess were obtained, nor any further information regarding the findings during the second surgery.Absent further information, no conclusions can be drawn.Based on documented experience with post-operative infections it is unlikely that the abscess 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 the event.Tela bio (importer) is submitting this report on behalf of aroa biosurgery (manufacturer) via exemption number e2017045.
Event or Problem Description
A ventral hernia repair was performed with ovitex 2s p on (b)(6) 2019.It was reported that the patient developed an abscess a few weeks after surgery which did not resolve with percutaneous drains.The patient underwent a second surgery on approximately (b)(6) 2019 in which the implant was found partially digested.The surgeon removed the implant.

• 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: 8683048
• Report Number: 3007321028-2019-00006
• Device Sequence Number: 2257003
• Product Code: FTM
• UDI-Device Identifier: 09421904065192
• UDI-Public: 09421904065192
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K153632
• 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): 06/10/2019
• Report Date (Section F): 05/17/2019

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: 12/31/2019
• Device Catalogue Number: F10248-1822P
• Device Lot Number: ERT-8A07
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/17/2019
• Device Age: 16 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/17/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 06/10/2019
• 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