MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 133FV TISSUE EXPANDER; EXPANDER, SKIN, INFLATABLE

Model Number	133FV-12
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/01/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.The event of "infection (unknown onset)" 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: use error and infection (unknown onset).
Event or Problem Description
Patient reported left side "infection and use error." patient additionally reported "bone aches." this event is not device related.Device has been explanted and replaced.

• Brand Name: STYLE 133FV TISSUE EXPANDER
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 15312591
• Report Number: 9617229-2021-54553
• Device Sequence Number: 2595096
• Product Code: LCJ
• UDI-Device Identifier: 10888628003934
• UDI-Public: 10888628003934
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K862203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 05/10/2019
• Device Model Number: 133FV-12
• Device Catalogue Number: 133FV-12
• Device Lot Number: 2756935
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 08/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2015
• 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
• Concomitant Medical Products and Therapy/Usage Dates: IV ANTIBIOTICS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female