MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 133FX TISSUE EXPANDER WITH SUTURE TAB; EXPANDER, SKIN, INFLATABLE

Model Number	133FX-13-T
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cellulitis (1768); Unspecified Infection (1930)
Date of Event	08/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.A review of the device history record has been completed.No deviations or non-conformances noted.Further investigation results: with the information collected during the investigation, there was enough evidence to support that the device was manufactured under controlled conditions in accordance with allergan medical procedures.Seal strength results were acceptable.Environmental monitoring results were found to be acceptable and were confirmed that there was not an adverse impact on environmental conditions, device quality or performance.The sterilization run was not related to any additional complaint infection record reported at time of investigation.Considering that there was not an adverse trend for this type of event no additional actions are deemed required at this time.The issues with infection will continue to be monitored and corrective action will be taken in the future if deemed appropriate.Given the fact that the cause of the infection could not be specifically associated to costa rica manufacturing process, and there was not an adverse trend for this type of event, no corrective action is deemed necessary at this time.The event of "infection" is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Reason for reoperation: infection (unknown onset).
Event or Problem Description
Healthcare professional reported left side ¿infection¿ and the tissue expander remained implanted for greater than six months.Device has been explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b.3., d.4., d.6a., g.1.
Event or Problem Description
Healthcare professional reported left side ¿infection¿ and the tissue expander remained implanted for greater than six months.Device has been explanted.
Event or Problem Description
Healthcare professional also reported ¿cause of infection was cellulitis.¿.

• Brand Name: STYLE 133FX TISSUE EXPANDER WITH SUTURE TAB
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 9601099
• Report Number: 9617229-2020-00210
• Device Sequence Number: 19586248
• Product Code: LCJ
• UDI-Device Identifier: 10888628004306
• UDI-Public: 10888628004306
• Combination Product (Y/N): N
• Initial Reporter State: GA
• PMA/510(K) Number: K102806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/11/2021

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: 12/16/2021
• Device Model Number: 133FX-13-T
• Device Catalogue Number: 133FX-13-T
• Device Lot Number: 3152528
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/10/2019
• Supplement Date Received by Manufacturer: 12/01/2020; 01/13/2021
• Initial Report FDA Received Date: 01/17/2020
• Supplement Report FDA Received Date: 12/29/2020; 02/11/2021
• 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: 45 YR