MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE TE SMOOTH 133S-MV-15-T; EXPANDER, SKIN, INFLATABLE

Model Number	133S-MV-15-T
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Failure of Implant (1924); Seroma (2069)
Date of Event	01/20/2023
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: deflation.
Event or Problem Description
Healthcare professional reported a right side "deflated tissue expanders due to radiation".The device has been explanted.
Event or Problem Description
Healthcare professional reported right side "deflated tissue expanders due to radiation", "the tabs had ripped away from the body of the expander" and leaving the device implanted longer than labeling indicates.Physician additionally reported "tissue expander has biological fluid", "unknown how fluid filled tissue expander" and "possible defects in tissue expanders." the device has been explanted.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: ¿ deflation/ use error: observed an opening on radius assessed as surgical damage, observed an opening on insert assembly assessed as an unidentified (tear) opening (shell thickness within spec) ¿ other technical: observed a broken suture tab assessed as an unidentified (tear) opening and observed missing suture tab assessed as inconclusive.Additional observations: ¿ crease fold and wear abrasion observed inside the device.¿ red particles observed inside the device.¿ yellow particles observed the outside of the device.¿ observed thread to suture on suture tab.No further actions are required as the device was implanted.The event of "seroma-late" is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.

• Brand Name: NATRELLE TE SMOOTH 133S-MV-15-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: 16370943
• Report Number: 9617229-2023-02188
• Device Sequence Number: 12605203
• Product Code: LCJ
• UDI-Device Identifier: 10888628043893
• UDI-Public: 10888628043893
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K182054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2023

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 Expiration Date: 05/22/2026
• Device Model Number: 133S-MV-15-T
• Device Catalogue Number: 133S-MV-15-T
• Device Lot Number: 3529833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/25/2023
• Supplement Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 02/14/2023
• Supplement Report FDA Received Date: 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2021
• 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: 51 YR
• Patient Sex: Female
• Patient Weight: 104 KG