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

Model Number	P20163-1620G
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	02/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent bilateral prepectoral breast reconstruction with ovitex prs (ltr) and tissue expanders on 19jan24.The right breast presented with seroma and the ovitex prs (ltr) device and tissue expander were removed on 23feb24.The patient was recovering as of 01mar23 with no additional adverse effects noted.
Additional Manufacturer Narrative
Seroma and reoperation are common adverse events after breast reconstruction surgery.As an identical device was implanted on the contralateral side without issue, it is unlikely that the device is the root cause of the event.However, it cannot be determined whether the device caused or contributed to the seroma and need for reoperation.A batch record review is currently underway.A supplemental report will be submitted if the results of this review provide information regarding the potential cause of this event.

• Brand Name: OVITEX PRS (LTR)
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): TELA BIO; 1 great valley parkway; suite 24; malvern PA 19355
• Manufacturer Contact: john urtz ; 1 great valley parkway; suite 24; malvern, PA 19355 ; 4843202884
• MDR Report Key: 18989539
• Report Number: 3010513348-2024-00008
• Device Sequence Number: 8208460
• Product Code: FTM
• UDI-Device Identifier: 00810055070183
• UDI-Public: 00810055070183
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K214070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/27/2024

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: 07/31/2024
• Device Model Number: P20163-1620G
• Device Catalogue Number: P20163-1620G
• Device Lot Number: ERT-23H05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 03/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/08/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female