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

Model Number	133S-MX-15-T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformance noted.Reason for reoperation: device appeared to be deflating during the expansion process.Device evaluation: visual analysis of the photographs identified: device patch with lot (or catalog) number it is not possible to see the batch number and catalog of the device due to the quality of the photos.A tissue expander device is observed which through the attached photo shows openings.Device analysis performed through photographs, due to the impossibility to perform microscopic analysis it is not possible to determine the most likely failure mode.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.
Event or Problem Description
Healthcare professional reported a device "appeared to be deflating during the expansion process", and "they were not able to put much volume in this expander at the time of implantation." device has been explanted.
Event or Problem Description
Healthcare professional reported a device "appeared to be deflating during the expansion process", and "they were not able to put much volume in this expander at the time of implantation." device has been explanted.

• Brand Name: NATRELLE TE SMOOTH 133S-MX-15-T
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 10599448
• Report Number: 9617229-2020-15755
• Device Sequence Number: 19804792
• Product Code: LCJ
• UDI-Device Identifier: 10888628044210
• UDI-Public: 10888628044210
• Combination Product (Y/N): N
• Initial Reporter State: WI
• PMA/510(K) Number: K182054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/08/2024
• Device Model Number: 133S-MX-15-T
• Device Catalogue Number: 133S-MX-15-T
• Device Lot Number: 3377212
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/01/2020
• Supplement Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 09/29/2020
• Supplement Report FDA Received Date: 04/05/2021
• 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: Other; Required Intervention