MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE TE SMOOTH 133S-MX-14-T; EXPANDER, SKIN, INFLATABLE

Model Number	133S-MX-14-T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Necrosis (1971)
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 completed.No deviations or non-conformances noted.The event of "necrosis" is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Reason for reoperation: necrosis and other-technical "break".
Event or Problem Description
Healthcare professional reported left side "necrosis" and "upon opening the skin noticed one of the tabs had come off of the expander, surgeon needed to scrap everything, and start over with a new device." device has been explanted and discarded after surgery.

• Brand Name: NATRELLE TE SMOOTH 133S-MX-14-T
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 10424532
• Report Number: 9617229-2020-09490
• Device Sequence Number: 16830182
• Product Code: LCJ
• UDI-Device Identifier: 10888628044203
• UDI-Public: 10888628044203
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Date (Section B): 08/19/2020

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: 11/05/2024
• Device Model Number: 133S-MX-14-T
• Device Catalogue Number: 133S-MX-14-T
• Device Lot Number: 3393054
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2020
• Initial Report FDA Received Date: 08/19/2020
• 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