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

Model Number	133S-MX-13-T
Medical Device Problem Codes	Fluid/Blood Leak (1250); Device Handling Problem (3265)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances 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: "17 months after being implanted, one of the breast expanders ruptured".
Event or Problem Description
Patient reported via regulatory agency for unknown side "17 months after being implanted, one of the breast expanders ruptured".The tissue expander remained implanted for more than 6 months.The status of the device is unknown.
Event or Problem Description
Physician reported right side "deflated tissue expander".The device has been replaced.

• Brand Name: NATRELLE TE SMOOTH 133S-MX-13-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: 14876369
• Report Number: 9617229-2022-11712
• Device Sequence Number: 5194926
• Product Code: LCJ
• UDI-Device Identifier: 10888628044197
• UDI-Public: 10888628044197
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K182054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2022

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: 05/11/2024
• Device Model Number: 133S-MX-13-T
• Device Catalogue Number: 133S-MX-13-T
• Device Lot Number: 3349027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2022
• Supplement Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2019
• 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: 45 YR
• Patient Sex: Female
• Patient Weight: 73 KG