MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE TE SMOOTH 133S-MV-14-T; EXPANDER, SKIN, INFLATABLE

Model Number	133S-MV-14-T
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Unspecified Infection (1930); Necrosis (1971)
Date of Event	05/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
In response to fda report number: mw5088920.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The events of infection (early onset), wound dehiscence, and necrosis are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.The reason for reoperation was infection (early onset), use error, wound dehiscence, and necrosis.Allergan did not submit this mdr within 30 days of becoming aware.Recent stimulated reporting related to 2011068-7/2/19-001-r has increased complaint and mdr volume.Allergan is implementing a plan to address the increased volumes.
Event or Problem Description
Patient reported via regulatory agency "left breast became tender with redness and swelling," "drain," "pseudomonas," "thick yellow drainage," "pin size hole in incision line opened up," "pencil eraser size hole in skin," "hole size of a dime," "left incision line developed an area of black tissue," "black tissue falls off" and "auto-immune trigger since the placement" of a tissue expander.Treatment with antibiotics and surgical intervention of "wash left breast and expander" occurred.Device has been explanted.

• Brand Name: NATRELLE TE SMOOTH 133S-MV-14-T
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 9732176
• Report Number: 9617229-2020-03614
• Device Sequence Number: 14270331
• Product Code: LCJ
• UDI-Device Identifier: 10888628043886
• UDI-Public: 10888628043886
• Combination Product (Y/N): N
• PMA/510(K) Number: K182054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/20/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 133S-MV-14-T
• Device Catalogue Number: 133S-MV-14-T
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 02/20/2020
• 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: Required Intervention