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

Catalog 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
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.Reason for reoperation: deflation.
Event or Problem Description
Healthcare professional reported a tissue expander that burst apart during surgery and ¿doctor had planned to take the right side expander and move it to the left side¿.Device has been explanted.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.Device evaluation: visual analysis of the returned device identified wear abrasion, flat creases, and brown particles.Leak test and microscopic analysis were performed and identified more than three curved openings with striated edges and curved sharp edge openings on suture tap.Based on the device analysis the final assessment was more than three curved striated openings assessed as surgical damage, and curved sharp edge openings assessed as unidentified (tear) opening.
Event or Problem Description
Healthcare professional reported a tissue expander that burst apart during surgery and ¿doctor had planned to take the right side expander and move it to the left side¿.Device has been 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: 9430128
• Report Number: 9617229-2019-21487
• Device Sequence Number: 2687078
• 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,Followup
• Report Date (Section B): 01/07/2020

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 Catalogue Number: 133S-SX-15-T
• Device Lot Number: 3355273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 12/06/2019
• Supplement Report FDA Received Date: 01/07/2020
• 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