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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Voluntary mw sent : 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 event of infection(early onset) is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.The reason for reoperation was infection(early onset).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 right side "swollen and red," and "pseudomonas" infection and "auto-immune trigger since the placement" of a tissue expander.Treatment with antibiotics and surgical intervention of "incision removed and sutured back." 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: 9734687
• Report Number: 9617229-2020-03615
• Device Sequence Number: 3128773
• 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