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

Model Number	133S-SX-13-T
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported unknown side "exchange on a patient who¿s te was deflated.We believe this to be a result of their dog jumping on their chest, but want to send in the implant to be sure." the device has been explanted and replaced.
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.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified flat creases, yellow particles in device inner surface and one curved opening at the edge of the insert to shell bond area in the anterior 1 location.A microscopic analysis and leak test were performed which identified that the curved opening has a sharp pattern.A dimension measurement in the shell was performed which identified the thickness within specification.The measurement of the opening is 4.0 mm.Creases/folding of implant condition that was indicated in the complaint was observed, nevertheless it is considered non-related to the manufacturing process, since the device was received out of their primary packaging and is an explanted device.Based on the device analysis the final assessment is: an opening with a sharp pattern at the edge of the insert to shell bond area assessed as an unidentified (tear) opening.Creases/folding of implant condition was observed, nevertheless is not related to the manufacturing process.
Event or Problem Description
Healthcare professional reported unknown side "exchange on a patient who¿s te was deflated.We believe this to be a result of their dog jumping on their chest, but want to send in the implant to be sure." the device has been explanted and replaced.

• Brand Name: NATRELLE TE SMOOTH 133S-SX-13-T
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer Contact: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 12779929
• Report Number: 9617229-2021-55891
• Device Sequence Number: 5749023
• Product Code: LCJ
• UDI-Device Identifier: 10888628043954
• UDI-Public: 10888628043954
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K182054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2021

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: 08/10/2025
• Device Model Number: 133S-SX-13-T
• Device Catalogue Number: 133S-SX-13-T
• Device Lot Number: 3462146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 11/11/2021
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female