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

Model Number F10244-1020P

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 06/04/2020

Event Type  Injury  

Manufacturer Narrative

No device problem was found from review of the dhr.The devices in ert-8f03 were produced as per established manufacturing procedures.All process specifications were met.

Event Description

It was reported that a patient experienced a potential "reaction" to an ovitex p mesh implanted on (b)(6) 2019.It was removed on (b)(6) 2020.

• Brand Name: OVITEX REINFORCED BIOSCAFFOLD
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): AROA BIOSURGERY LTD.; 2 kingsford smith place; airport oaks, auckland 2022 ; NZ 2022
• Manufacturer (Section G): AROA BIOSURGERY LTD.; 2 kingsford smith place; airport oaks, auckland 2022 ; NZ 2022
• Manufacturer Contact: tina obrien ; 2 kingsford smith place; airport oaks, auckland 2022 ; NZ 2022
• MDR Report Key: 10192611
• MDR Text Key: 199471199
• Report Number: 3007321028-2020-00008
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 09421904065031
• UDI-Public: 09421904065031
• 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: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: F10244-1020P
• Device Catalogue Number: F10244-1020P
• Device Lot Number: ERT-8F03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2018
• 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
• Patient Age: 48 YR
• Patient Weight: 60