MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE TE SMOOTH 133S-FV-12-T; EXPANDER, SKIN, INFLATABLE

Catalog Number	133S-FV-12-T
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Company representative reported on behalf of physician, ¿the implanted tissue expander had deflated".This record is for unknown side.The device remains implanted.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.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: deflation.
Additional Manufacturer Narrative
Additional, corrected and/or changed data: a.4, b.5, d.6b, d.9, h.3, h.6.
Event or Problem Description
Company representative reported on behalf of physician, ¿the implanted tissue expander had deflated".Physician later reported "hole, non-specific." this record is for the left side.The device has been explanted.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: deflation: observed openings striated on anterior side assessed as surgical damage.And broken striated on suture tab.And missing piece of shell assessed as inconclusive.Additional observations: fluids observed.
Event or Problem Description
Company representative reported on behalf of physician, ¿the implanted tissue expander had deflated".Physician later reported "hole, non-specific." this record is for the left side.The device has been explanted.

• Brand Name: NATRELLE TE SMOOTH 133S-FV-12-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: 17668337
• Report Number: 9617229-2023-14155
• Device Sequence Number: 20614002
• Product Code: LCJ
• UDI-Device Identifier: 10888628043787
• UDI-Public: 10888628043787
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K102806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/25/2023

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-FV-12-T
• Device Lot Number: 3626046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2023
• Supplement Date Received by Manufacturer: 09/05/2023; 10/04/2023
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 09/28/2023; 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2022
• 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 Age: 56 YR
• Patient Sex: Female
• Patient Weight: 65 KG