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

Model Number	133S-FV-12-T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
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.The reason for reoperation: portion of the front of the expander sticking to the back, device did not fill.
Event or Problem Description
Non-healthcare professional reported that the portion of the front of the expander sticking to the back.Device not implanted.
Event or Problem Description
Non-healthcare professional reported that the portion of the front of the expander sticking to the back.Device not implanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified: crease flat.Leak test was performed, and no leakage was found.Based on the device analysis the final assessment is: no issues found related with the manufacturing process.No openings or issues related to broken device were observed.

• 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: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 13865360
• Report Number: 9617229-2022-04337
• Device Sequence Number: 6357505
• Product Code: LCJ
• UDI-Device Identifier: 10888628043787
• UDI-Public: 10888628043787
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K102806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2022

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: 11/04/2025
• Device Model Number: 133S-FV-12-T
• Device Catalogue Number: 133S-FV-12-T
• Device Lot Number: 3480734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/24/2022
• Supplement Date Received by Manufacturer: 03/23/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 05/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2020
• 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