MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE TE SMOOTH 133S-MX-12-T; EXPANDER, SKIN, INFLATABLE

Model Number	133S-MX-12-T
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/13/2023
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: magna-site needle guard dislodgement.
Event or Problem Description
Company representative reported via a healthcare provider that the healthcare provider "explanted a tissue expander today for a unknown side and the "magnet detached out of the back and was floating in the expander".The device has been explanted.
Additional Manufacturer Narrative
Photo analysis.Visual analysis of the photos identified: magna-site needle guard dislodgment: observed but cannot be assessed as a workmanship since the device is out of the sealed package and was implanted, however, a further investigation will be requested to review the event of dislodged needle guard.
Event or Problem Description
Company representative reported via a healthcare provider that the healthcare provider "explanted a tissue expander today for a unknown side and the "magnet detached out of the back and was floating in the expander".The device has been explanted.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: magna-site needle guard dislodgment: observed dislodged needle guard, it is not considered a workmanship since the device was implanted.Use error: unable to observe since it is not related to the device.Additional observations: fluids observed.No further actions are required as the device was implanted.
Event or Problem Description
Company representative reported via a healthcare provider that the healthcare provider "explanted a tissue expander today for a unknown side and the "magnet detached out of the back and was floating in the expander".The device has been explanted.

• Brand Name: NATRELLE TE SMOOTH 133S-MX-12-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: 16819938
• Report Number: 9617229-2023-07367
• Device Sequence Number: 7124647
• Product Code: LCJ
• UDI-Device Identifier: 10888628044180
• UDI-Public: 10888628044180
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K182054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/15/2023

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 Model Number: 133S-MX-12-T
• Device Catalogue Number: 133S-MX-12-T
• Device Lot Number: 3583013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2023
• Supplement Date Received by Manufacturer: 05/15/2023; 08/22/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 06/05/2023; 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2022
• 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: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female