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

Catalog Number 133S-FX-13-T

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Foreign Body Reaction (1868)

Event Date 08/08/2023

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: inferior tab torn away from tissue expander and exposure.

Event Description

Allergan representative reported "inferior tab that was dislodged in the pocket of the patient and caused it to be exposed with a scab.Upon removal of the tissue expander it was identified that the inferior tab had torn away from tissue expander." tissue expander has been explanted and replaced.

Event Description

Allergan representative reported "inferior tab that was dislodged in the pocket of the patient and caused it to be exposed with a scab.Upon removal of the tissue expander it was identified that the inferior tab had torn away from tissue expander." tissue expander has been explanted and replaced.

Manufacturer Narrative

Device evaluation: based on the device analysis grid, the assessments of the complaint are: ¿ exposure: unable to observe since it is not related to the device.¿ other-technical: observed 6 o¿clock position suture tab was separated from the device.Additional observations: ¿ the piece of suture tab is missing assessed as inconclusive.¿ total delamination of suture tab at the 6 o¿clock position assessed as adhesive failure.¿ observed an opening on radius assessed as surgical damage.¿ brown particles observed outside the device.No further actions are required as the device was implanted.

• Brand Name: NATRELLE TE SMOOTH 133S-FX-13-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: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 17659587
• MDR Text Key: 322361053
• Report Number: 9617229-2023-14325
• Device Sequence Number: 1
• Product Code: LCJ
• UDI-Device Identifier: 10888628044036
• UDI-Public: 10888628044036
• 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: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 133S-FX-13-T
• Device Lot Number: 3598846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2022
• 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