MAUDE Adverse Event Report: MENTOR TEXAS MEDIUM HEIGHT TE 650CC; EXPANDER, SKIN, INFLATABLE

Catalog Number	3548215
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	06/30/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because the no lot number was provided by the customer.
Event or Problem Description
Event description: this complaint is from a literature source.As reported in the literature publication entitled, "local safety of immediate reconstruction during primary treatment of breast cancer.Direct-to-implant versus expander-based surgery." a (b)(6) female patient who underwent expander-based reconstruction (ebr) in two stages has experienced seroma.Objectives: this study investigated the factors that could lead to major or minor complications after expander- based versus direct-to-implant (dti) reconstruction.Methods: the studied factors were age, body mass index (bmi), hypertension, smoking, diabetes, type of mastectomy (nipple-sparing/total), implant size, neoadjuvant/adjuvant chemotherapy, and radiotherapy.The study sample included 294 immediate reconstructions over 3 years.The primary outcome was the incidence of complications, major or minor depending on the necessity of revision surgery.For the dti pocket, we applied a variant of the conventional submuscular technique.The study population comprised 262 women undergoing 294 immediate reconstructions after mastectomy (32 bilateral cases) at (b)(6) from december 2011 to june 2014.

• Brand Name: MEDIUM HEIGHT TE 650CC
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 8335455
• Report Number: 1645337-2019-08333
• Device Sequence Number: 154965
• Product Code: LCJ
• UDI-Device Identifier: 00081317006565
• UDI-Public: 00081317006565
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/25/2019

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 Catalogue Number: 3548215
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2019
• Initial Report FDA Received Date: 02/13/2019
• 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: Required Intervention
• Patient Age: 68 YR