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

Catalog Number	F10254-2020G
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Multiple attempts were made to contact the surgeon who performed the breast reconstruction and no information was received.It is unknown whether the device caused or contributed to this event or it was due to other factors such as other devices used, surgical technique, or other circumstances.The company continues to attempt to retreieve more information.Tela bio (importer) is submitting this report on behalf of aroa biosurgery (manufacturer) via exemption number e2017045.
Event or Problem Description
A patient reported that she underwent bilateral breast reconstruction in which ovitex was utilized.She reported that sometime after the procedure that she believed that the mesh did not stay in place in one breast and the implant "almost literally fell out".The breast implant ended up being surgically removed.

• Brand Name: OVITEX REINFORCED BIOSCAFFOLD
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): AROA BIOSURGERY; 2 kingsfordsmith place; airport oaks; auckland 2022 ; NZ 2022
• MDR Report Key: 8190303
• Report Number: 3007321028-2018-00002
• Device Sequence Number: 1997495
• Product Code: FTM
• UDI-Device Identifier: 09421904065277
• UDI-Public: 09421904065277
• Combination Product (Y/N): N
• PMA/510(K) Number: K153633
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/21/2018
• Report Date (Section F): 11/30/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: F10254-2020G
• Device Lot Number: ERT-8C06
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/29/2018
• Device Age: 8 MO
• Event Location: Other
• Date Report to Manufacturer: 11/30/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 12/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention