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

Model Number	133S-MV-12-T
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Healthcare professional reported via journal article titled "dislodgement of tissue expander ports in a patient without trauma or mri history" that the magnetic port of a tissue expander became dislodged on left side.The tissue expander was implanted for a period greater than six months.The device has been explanted and replaced.
Additional Manufacturer Narrative
Article citation: lowenthal, c.F., truong, a.Y., & ascherman, j.A.(2021).Dislodgement of tissue expander ports in a patient without trauma or mri history.Jpras open, 31, 29-31.Https://doi.Org/10.1016/j.Jpra.2021.10.005.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: device replacement.

• Brand Name: NATRELLE TE SMOOTH 133S-MV-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: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 13052302
• Report Number: 9617229-2021-59882
• Device Sequence Number: 3951283
• Product Code: LCJ
• UDI-Device Identifier: 10888628043862
• UDI-Public: 10888628043862
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K182054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 133S-MV-12-T
• Device Catalogue Number: 133S-MV-12-T
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 12/21/2021
• 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: 56 YR
• Patient Sex: Female