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 Codes	Deflation Problem (1149); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/15/2021
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 unknown 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: curved opening, wear abrasion.Leak test and microscopic analysis was performed which identified: a curved sharp opening on stable base assessed as unidentified(tear) opening(no shell thickness due to opening is under stable base) and a curved striated opening on anterior side assessed as surgical damage.Based on the device analysis the final assessment is: a sharp opening assessed as unidentified(tear) opening.A curved striated opening assessed as surgical damage consist in the use of some surgical tool.
Event or Problem Description
Healthcare professional reported right side "slow leak.".

• 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
• MDR Report Key: 11347597
• Report Number: 9617229-2021-01387
• Device Sequence Number: 16791734
• Product Code: LCJ
• UDI-Device Identifier: 10888628043909
• UDI-Public: 10888628043909
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K182054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/08/2021

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: 11/13/2024
• Device Model Number: 133S-MV-16-T
• Device Catalogue Number: 133S-MV-16-T
• Device Lot Number: 3393026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Initial Date Received by Manufacturer: 01/21/2021
• Supplement Date Received by Manufacturer: 03/23/2021; 05/11/2021
• Initial Report FDA Received Date: 02/19/2021
• Supplement Report FDA Received Date: 04/20/2021; 06/08/2021
• 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
• Patient Weight: 82