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

Model Number 133S-FX-12-T

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformances noted.The event of "infection" is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.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: infection (unknown onset) and exposure.

Event Description

Healthcare professional reported a left side infection (unknown onset) and exposure."patient did not heal properly after mastectomy and developed open wound with infection and exposure of tissue expander." device has been explanted.

• Brand Name: NATRELLE TE SMOOTH 133S-FX-12-T
• Type of Device: 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: 13564182
• MDR Text Key: 285982588
• Report Number: 9617229-2022-01684
• Device Sequence Number: 1
• Product Code: LCJ
• UDI-Device Identifier: 10888628044029
• UDI-Public: 10888628044029
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 133S-FX-12-T
• Device Catalogue Number: 133S-FX-12-T
• Device Lot Number: 3423673
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female