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

Catalog Number	133S-MX-13-T
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Purulent Discharge (1812)
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported "cultures have recently been performed on mammary drains in which pseudomonas aeruginosa has grown".This record is for the unknown side.Device has been explanted.
Additional Manufacturer Narrative
The reported events are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.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: drainage and infection (unknown onset).
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.
Event or Problem Description
Healthcare professional reported "cultures have recently been performed on mammary drains in which pseudomonas aeruginosa has grown".This record is for the unknown side.Device has been explanted.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.
Event or Problem Description
Healthcare professional reported "cultures have recently been performed on mammary drains in which pseudomonas aeruginosa has grown".This record is for the unknown side.Device has been explanted.

• 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: 17926701
• Report Number: 9617229-2023-16927
• Device Sequence Number: 2893861
• Product Code: LCJ
• UDI-Device Identifier: 10888628044197
• UDI-Public: 10888628044197
• 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: Other,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/19/2023

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 Catalogue Number: 133S-MX-13-T
• Device Lot Number: 3659312
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/20/2023
• Supplement Date Received by Manufacturer: 10/17/2023; 11/30/2023
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 11/14/2023; 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2022
• 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 Sex: Female