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

Model Number	P20263-1020G
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	04/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Seroma and reoperation are known adverse events that may occur with or without the use of additional support in expander based breast reconstruction.It is unclear in this specific case whether the device caused or contributed to the events noted.In discussion with the surgeon it was noted that patient tissue quality may have contributed to delayed healing and subsequent seroma.
Event or Problem Description
A patient underwent bilateral prepectoral two stage breast reconstruction with tissue expanders and ovitex prs.Within approximately two weeks, one side developed a seroma.On the contralateral side drainage was noted through the surgical wound.The surgeon removed both tissue expanders and ovitex prs devices.

• 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: 19330854
• Report Number: 3010513348-2024-00010
• Device Sequence Number: 7003596
• Product Code: FTM
• UDI-Device Identifier: 00810055070770
• UDI-Public: 00810055070770
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 05/16/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Model Number: P20263-1020G
• Device Catalogue Number: P20263-1020G
• Device Lot Number: ERT-23J20
• 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: 04/22/2024
• Initial Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2023
• 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