MAUDE Adverse Event Report: STYLE 133MV TISSUE EXPANDER WITH SUTURE TAB; EXPANDER, SKIN, INFLATABLE

Model Number	133MV-14-T
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted beyond 30-calendar days from allergan¿s receipt due to the exemption transition period.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 information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Reason for reoperation: obtained device information from dt form.The form indicates the saline tissue expander was filled with "500cc air"; use error.It is unknown if the device has been explanted or remains implanted.
Event or Problem Description
Health professional reported a right side "500cc air"; use error during implant procedure.It is unknown if the device has been explanted or remains implanted.

• Brand Name: STYLE 133MV TISSUE EXPANDER WITH SUTURE TAB
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• MDR Report Key: 10656336
• Report Number: 9617229-2020-07595
• Device Sequence Number: 3552142
• Product Code: LCJ
• UDI-Device Identifier: 10888628004436
• UDI-Public: 10888628004436
• Combination Product (Y/N): N
• Initial Reporter State: IA
• PMA/510(K) Number: K102806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/09/2020

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 Expiration Date: 06/07/2022
• Device Model Number: 133MV-14-T
• Device Catalogue Number: 133MV-14-T
• Device Lot Number: 3224990
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 10/09/2020
• 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: Other