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

Model Number F10244-1218L

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Seroma (2069)

Event Date 11/22/2023

Event Type  Injury  

Event Description

It was reported that a patient complained of post operative pain after ventral/incisional hernia repair with ovitex lpr.After medication did not resolve the issue, an exploratory operation was performed.Upon reoperation, fluid collection was noted; further, adhesions were noted that were easily freed with blunt dissection.The device was removed and replaced with an alternative reinforcement material.

Manufacturer Narrative

No device problem was found from the review of the dhr.The devices in ert-21l01 were produced as per established manufacturing procedures.All process specifications including package labelling requirements were met.

• Brand Name: OVITEX LPR
• 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: 18412305
• MDR Text Key: 331581818
• Report Number: 3007321028-2023-00038
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 09421904065796
• UDI-Public: 09421904065796
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130547
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/29/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: F10244-1218L
• Device Catalogue Number: F10244-1218L
• Device Lot Number: ERT-21L01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2203
• Initial Date FDA Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2021
• 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): Required Intervention; Hospitalization
• Patient Age: 42 YR
• Patient Sex: Female