MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE TE SMOOTH 133S-MX-13-T, 500CC; EXPANDER, SKIN, INFLATABLE

Catalog Number J133S-MX-13-T

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Foreign Body Reaction (1868); Necrosis (1971)

Event Date 01/18/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter name and address: (b)(6).The events of "corner of te reached the skin and bedsore presented" 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: "bending of te [tissue expander]," and "corner of te reached the skin and bedsore presented.".

Event Description

Healthcare professional reported unspecified side "bending of te [tissue expander]," and "corner of te reached the skin and bedsore presented." device was explanted and "replaced with imp.".

Event Description

Healthcare professional reported unspecified side "bending of te [tissue expander]," and "corner of te reached the skin and bedsore presented." device was explanted and "replaced with imp.".

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformances noted.

• Brand Name: NATRELLE TE SMOOTH 133S-MX-13-T, 500CC
• 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: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 12017635
• MDR Text Key: 256745960
• Report Number: 9617229-2021-46948
• Device Sequence Number: 1
• Product Code: LCJ
• UDI-Device Identifier: 04987836037256
• UDI-Public: 4987836037256
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/13/2022
• Device Catalogue Number: J133S-MX-13-T
• Device Lot Number: 3403058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2020
• 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