MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE TE SMOOTH 133S-SX-15-T; EXPANDER, SKIN, INFLATABLE

Model Number	133S-SX-15-T
Medical Device Problem Codes	Fluid/Blood Leak (1250); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Allergan did not submit this mdr within 30 days of becoming aware.Recent stimulated reporting related to 2011068-7/2/19-001-r has increased complaint and mdr volume.Allergan is implementing a plan to address the increased volumes.  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.Device evaluation: visual analysis of the returned device identified an opening and wear abrasion.Leak test was performed and found opening on radius.A microscopic analysis was performed which identified a striated edge opening in the radius and broken sharp edge in the suture tab.Based on the device analysis the final assessment was a striated edge opening on radius side due to surgical damage, and a broken striated edge in the suture tab due to an unidentified (tear) opening.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 and use error.
Event or Problem Description
Healthcare professional reported left side "burst apart" and ¿doctor had planned to take the right side expander and move it to the left side¿.Device was explanted.

• Brand Name: NATRELLE TE SMOOTH 133S-SX-15-T
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 9682581
• Report Number: 9617229-2020-01494
• Device Sequence Number: 3414701
• Product Code: LCJ
• UDI-Device Identifier: 10888628043978
• UDI-Public: 10888628043978
• Combination Product (Y/N): N
• Initial Reporter State: MS
• PMA/510(K) Number: K182054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/07/2020

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: 06/01/2024
• Device Model Number: 133S-SX-15-T
• Device Catalogue Number: 133S-SX-15-T
• Device Lot Number: 3355272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 02/07/2020
• 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
• Patient Age: 51 YR