MAUDE Adverse Event Report: TELA BIO OVITEX PRS; SURGICAL MESH

Model Number	R20152-2020G
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the patient was non-compliant with her drains after surgery.It is unknown whether this caused or contributed to the event or whether the indication for the follow-up surgical procedure was related to the noted state of the ovitex prs.A dhr review revealed no anomalies that may have caused or contributed to this event.
Event or Problem Description
A patient underwent a unilateral (left) mastectomy and prefectoral two-stage breast reconstruction with a textured tissue expander and ovitex prs.The expander and ovitex prs were implanted on (b)(6) 2020.The patient returned on (b)(6) 2020 for an unknown follow-up surgical procedure.Upon opening the incision, the surgeon noted that portions of the ovine tissue were no longer present at the surgical site.The surgeon removed the ovitex prs and left the expander inserted.

• Brand Name: OVITEX PRS
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): TELA BIO; 1 great valley parkway; suite 24; malvern PA 19355
• MDR Report Key: 10822213
• Report Number: 3010513348-2020-00006
• Device Sequence Number: 3334418
• Product Code: FTM
• UDI-Device Identifier: 00856072005012
• UDI-Public: 00856072005012
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K183398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/14/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: R20152-2020G
• Device Catalogue Number: R20152-2020G
• Device Lot Number: ERT-20G02
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 11/11/2020
• 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