MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE TE SMOOTH 133S-SX-13-T; EXPANDER, SKIN, INFLATABLE

Model Number	133S-SX-13-T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.This is a known potential adverse event addressed in the product labeling.The reason for reoperation was/is broken device.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.Device evaluation: visual analysis of the returned device identified one curved opening, creases, and red particles in the device outer surface.Leak test and microscopic analysis was performed which identified one striated opening.Based on the device analysis the final assessment is: one opening striated assessed as surgical damage.
Event or Problem Description
Healthcare professional reported a not implanted device has a "puncture hole and began leaking." device was explanted.
Additional Manufacturer Narrative
Additional, changed and/or corrected data: d.4, d.6a, d.6b, h.4, h.6.
Event or Problem Description
Healthcare professional reported a not implanted device has a "puncture hole and began leaking." device was explanted.

• Brand Name: NATRELLE TE SMOOTH 133S-SX-13-T
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 9511918
• Report Number: 9617229-2019-20987
• Device Sequence Number: 2080048
• Product Code: LCJ
• UDI-Device Identifier: 10888628043954
• UDI-Public: 10888628043954
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2021

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: 04/11/2024
• Device Model Number: 133S-SX-13-T
• Device Catalogue Number: 133S-SX-13-T
• Device Lot Number: 3339921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Initial Date Received by Manufacturer: 10/04/2019
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 03/31/2021
• 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: Other; Required Intervention
• Patient Age: 54 YR