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

Model Number	133S-MX-12-T
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/10/2020
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.A review of the device history record has been completed.No deviations or non-conformance's noted.The device was not implanted.Surgery was completed with a backup device.
Event or Problem Description
Healthcare professional reported "deflation observed during implant surgery" and "suspected needle injury".The device was not implanted.Surgery was completed with a backup device.
Additional Manufacturer Narrative
Device evaluation: the device related to the reported event of use error, received on may 20, 2020 with lot number 3350729.Visual analysis of the returned device identified: two openings curved on the radius, white particles on the shell, orange particles in the shell and missing on the suture tab (0-25%).Leak test and microscopic analysis was performed which identified: two openings striated on the radius, non-penetrating nick striated and broken and broken striated on the suture tab.Based on the device analysis the final assessment is: - two striated openings assessed as surgical damage consist in the use of some surgical tool.- missing on the suture tab due to inconclusive.- non-penetrating nick striated assessed as surgical tool scratch like.- a striated broken on the suture tab assessed as surgical damage consist in the use of some surgical tool.
Event or Problem Description
Healthcare professional reported "deflation observed during implant surgery" and "suspected needle injury".The device was not implanted.Surgery was completed with a backup device.

• Brand Name: NATRELLE TE SMOOTH 133S-MX-12-T
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 9933617
• Report Number: 9617229-2020-05651
• Device Sequence Number: 665411
• Product Code: LCJ
• UDI-Device Identifier: 10888628044180
• UDI-Public: 10888628044180
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K182054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/21/2024
• Device Model Number: 133S-MX-12-T
• Device Catalogue Number: 133S-MX-12-T
• Device Lot Number: 3350729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2020
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 05/22/2020
• Initial Report FDA Received Date: 04/07/2020
• Supplement Report FDA Received Date: 06/18/2020
• 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: Other; Required Intervention
• Patient Age: 37 YR