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

Catalog Number	133S-FX-13-T
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Date of Event	08/08/2023
Type of Reportable Event	Serious Injury
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.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 or Problem 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 or Problem 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.
Additional 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
• 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: 17659587
• Report Number: 9617229-2023-14325
• Device Sequence Number: 6207954
• Product Code: LCJ
• UDI-Device Identifier: 10888628044036
• UDI-Public: 10888628044036
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K182054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2023

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-FX-13-T
• Device Lot Number: 3598846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2023
• Supplement Date Received by Manufacturer: 10/13/2023
• Initial Report FDA Received Date: 08/31/2023
• Supplement Report FDA Received Date: 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2022
• 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