MAUDE Adverse Event Report: AROA BIOSURGERY LTD. OVITEX REINFORCED BIOSCAFFOLD; SURIGAL MESH

Model Number F10248-1620P

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Seroma (2069)

Event Date 09/12/2019

Event Type  Injury  

Manufacturer Narrative

Despite repeated attempts, no further information was obtained.In the absence of further information, it is unknown whether the device in any way caused or contributed to this event.

Event Description

A patient who underwent a bridging hernia repair with ovitex 2sp on (b)(6) 2019 presented with a seroma approximately two weeks after surgery.It is reported that the patient was re-admitted to the operating room and that the surgeon found that the implant had been partially resorbed or digested and that the synthetic portion remained behind.The remaining portions were explanted.

• Brand Name: OVITEX REINFORCED BIOSCAFFOLD
• Type of Device: SURIGAL MESH
• Manufacturer (Section D): AROA BIOSURGERY LTD.; 2 kingsford smith place; airport oaks, 2022 ; NZ 2022
• Manufacturer (Section G): AROA BIOSURGERY LTD.; 2 kingsford smith place; airport oaks, 2022 ; NZ 2022
• Manufacturer Contact: tina obrien ; 2 kingsford smith place; airport oaks, auckland 2022 ; NZ 2022
• MDR Report Key: 9183911
• MDR Text Key: 164869016
• Report Number: 3007321028-2019-00015
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 09421904065185
• UDI-Public: 09421904065185
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153632
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: F10248-1620P
• Device Catalogue Number: F10248-1620P
• Device Lot Number: ERT-8B03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention