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

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

Patient Problems Adhesion(s) (1695); Hernia (2240)

Event Date 05/03/2022

Event Type  Injury  

Event Description

It was reported that a patient developed a hernia recurrence approximately 1-2 years after stoma closure and repair with ovitex rtm.Upon intraoperative examination, some dense adhesions were noted which needed careful dissecting (grade 4).The adhesions appeared to be mostly attached to the seamed area of the large sized device.The hernia recurrence was reported lateral to the original repair.

Manufacturer Narrative

Both hernia recurrence and adhesions are known potential adverse events associated with the use of surgical mesh in hernia repair.It was noted that the recurrence was lateral to the original repair and that the original repair remained intact and integrated.No information regarding the specific device model, lot, or other identifiable information was provided.

• Brand Name: OVITEX REINFORCED TISSUE MATRIX
• 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 o'brien ; 2 kingsford smith place; airport oaks, auckland 2022 ; NZ 2022
• MDR Report Key: 14982716
• MDR Text Key: 295679342
• Report Number: 3007321028-2022-00015
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K181935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male