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

Model Number	133S-FV-13-T
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Healthcare professional reported right side "slow leak".Device remains implanted.
Event or Problem Description
Device has been explanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified: white fluids in the shell and missing on the suture tab (0-25%).The unit does not leak, and microscopic analysis was performed which identified: broken striated on the suture tab and more than 3 openings striated on the suture tabs.Based on the device analysis the final assessment is: more than 3 striated openings on the suture tabs assessed as surgical damage consistent in the use of some surgical tool.Missing on the suture tab due to inconclusive.A striated broken on the suture tab assessed as surgical damage consistent in the use of some surgical tool.

• Brand Name: NATRELLE TE SMOOTH 133S-FV-13-T
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 10697614
• Report Number: 9617229-2020-16737
• Device Sequence Number: 16964400
• Product Code: LCJ
• UDI-Device Identifier: 10888628043794
• UDI-Public: 10888628043794
• Combination Product (Y/N): N
• Initial Reporter State: NV
• PMA/510(K) Number: K182054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2020

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: 04/18/2025
• Device Model Number: 133S-FV-13-T
• Device Catalogue Number: 133S-FV-13-T
• Device Lot Number: 3430232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Initial Date Received by Manufacturer: 09/21/2020
• Supplement Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 10/19/2020
• Supplement Report FDA Received Date: 11/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention