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

Model Number	133S-FX-14-T
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformance 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: deflation.
Event or Problem Description
Healthcare professional reported deflation with a tissue expander for an unknown side.Device has been explanted.
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.
Event or Problem Description
Healthcare professional reported deflation with a tissue expander for an unknown side.Device has been explanted and discarded.

• Brand Name: NATRELLE TE SMOOTH 133S-FX-14-T
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 10436109
• Report Number: 9617229-2020-12998
• Device Sequence Number: 3872658
• Product Code: LCJ
• UDI-Device Identifier: 10888628044043
• UDI-Public: 10888628044043
• Combination Product (Y/N): N
• Initial Reporter State: CA
• PMA/510(K) Number: K182054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2021

1 Device 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: 08/28/2024
• Device Model Number: 133S-FX-14-T
• Device Catalogue Number: 133S-FX-14-T
• Device Lot Number: 3373431
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2020
• Supplement Date Received by Manufacturer: 09/04/2020
• Initial Report FDA Received Date: 08/21/2020
• Supplement Report FDA Received Date: 04/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No