MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE TE SMOOTH 133S-MX-11-T, 300CC; EXPANDER, SKIN, INFLATABLE

Catalog Number J133S-MX-11-T

Device Problems Fluid/Blood Leak (1250); Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)

Patient Problems Capsular Contracture (1761); Failure of Implant (1924); Unspecified Infection (1930)

Event Date 05/01/2020

Event Type  Injury  

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: port leak and/or damage.

Event Description

Healthcare professional reports "suspected that the port part on the te has fallen off by the examination of echo and touch manipulation" against an unspecified side.The device remains implanted.

Manufacturer Narrative

The events of infection and capsular contracture are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.

Event Description

Healthcare professional reported that patient experienced ¿severe capsular contracture¿ and ¿porridge like substance surrounding which was thought to be evidence of infection¿.Te had ¿leakage from a pinhole¿ and ¿as the te (bended into upper and lower two parts) was inserted under the port within a small cramped pocket.The caudal part of the te was covered by the port.When doctor processed the saline injection, it was thought that it was punctured together with the needle¿.The device has been explanted.The event of deflation was deemed not device related.

• Brand Name: NATRELLE TE SMOOTH 133S-MX-11-T, 300CC
• Type of Device: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer Contact: michelle burgess ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 7372473605
• MDR Report Key: 10220574
• MDR Text Key: 197204767
• Report Number: 9617229-2020-10242
• Device Sequence Number: 1
• Product Code: LCJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K182054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/18/2022
• Device Catalogue Number: J133S-MX-11-T
• Device Lot Number: 3384601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2019
• 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