MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE TE SMOOTH 133S-MV-16-T; EXPANDER, SKIN, INFLATABLE

Model Number	133S-MV-16-T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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: broken device.
Event or Problem Description
Healthcare provider reported unknown side one of ¿allergan¿s tissue expanders had a hole in it.If i got the story correct it was implanted before they discovered the problem¿.The device has been explanted.
Event or Problem Description
Healthcare provider reported unknown side one of ¿allergan¿s tissue expanders had a hole in it.If i got the story correct it was implanted before they discovered the problem¿.The device has been explanted.
Event or Problem Description
Healthcare provider reported unknown side one of ¿allergan¿s tissue expanders had a hole in it.If i got the story correct it was implanted before they discovered the problem¿.The device has been explanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified: two openings on anterior.Leak test and microscopic analysis was performed which identified: two striated openings on anterior and non-penetrating nick striated on anterior.Based on the device analysis the final assessment is: two striated openings on anterior assessed as surgical damage.

• Brand Name: NATRELLE TE SMOOTH 133S-MV-16-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: 14689890
• Report Number: 9617229-2022-11117
• Device Sequence Number: 5175428
• Product Code: LCJ
• UDI-Device Identifier: 10888628043909
• UDI-Public: 10888628043909
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K182054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/11/2022

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: 02/16/2025
• Device Model Number: 133S-MV-16-T
• Device Catalogue Number: 133S-MV-16-T
• Device Lot Number: 3423734
• 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: 05/19/2022
• Supplement Date Received by Manufacturer: 06/15/2022; 07/18/2022
• Initial Report FDA Received Date: 06/14/2022
• Supplement Report FDA Received Date: 07/12/2022; 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2020
• 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