MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE TE SMOOTH 133S-MX-16-T; EXPANDER, SKIN, INFLATABLE

Model Number	133S-MX-16-T
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/14/2022
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.Reason for reoperation: other-technical.
Event or Problem Description
Healthcare professional reported unknown side "looks like it has either folded and caused the port to shift, or like the port has actually separated from the top of the expander and is floating in the middle.We were wondering if you have had any reported cases of expander defects where the port has collapsed or detached/separated from the shell¿.Device remains implanted.
Event or Problem Description
Healthcare professional reported "it looks like the expander has either folded and caused the port to shift, or like the port has actually separated from the top of the expander and is floating in the middle.We were wondering if you have had any reported cases of expander defects where the port has collapsed or detached/separated from the shell." this is for the right side.Device remains implanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5.

• Brand Name: NATRELLE TE SMOOTH 133S-MX-16-T
• 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: 15513260
• Report Number: 9617229-2022-16726
• Device Sequence Number: 17386324
• Product Code: LCJ
• UDI-Device Identifier: 10888628044227
• UDI-Public: 10888628044227
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K182054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2023

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: 10/23/2025
• Device Model Number: 133S-MX-16-T
• Device Catalogue Number: 133S-MX-16-T
• Device Lot Number: 3476955
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/06/2022
• Supplement Date Received by Manufacturer: 12/21/2022
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2020
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female