MAUDE Adverse Event Report: AROA BIOSURGERY LTD. OVITEX

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Seroma (2069)

Event Type  Injury  

Manufacturer Narrative

No information has been provided by the initial reporter indicating that the seroma was directly resultant of the ovitex device or the patient outcome.

Event Description

A seroma was reported after a surgery with ovitex (unknown).Multiple requests for additional information from the physician were made via the sales representative - no additional data reported as of (b)(6) 2017.

• Brand Name: OVITEX
• Type of Device: OVITEX
• Manufacturer (Section D): 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: 6854334
• MDR Text Key: 85597222
• Report Number: 3007321028-2017-00002
• 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: 09/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/16/2017
• 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): Other