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

Device Problem Degraded (1153)

Patient Problem Hernia (2240)

Event Type  Injury  

Manufacturer Narrative

Lot number and product code information were not received, thus prohibiting manufacturing review.

Event Description

A surgeon simultaneously reported three cases in which an infection developed after hernia repair with ovitex (exact part number unknown).It was reported that in the presence of these infections, varying amounts of the device dissolved, leaving the polypropylene suture behind.The surgeon re-operated to remove portions of the implant and remaining polypropylene.In this case a portion of the polypropylene was adherent to the bowel, and its removal required a resection of a small piece of bowel.This is 1 of 3 such cases reported.

• 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: 11234354
• MDR Text Key: 228853786
• Report Number: 3007321028-2020-00020
• Device Sequence Number: 1
• Product Code: FTM
• 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: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2020
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention