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

Model Number	133S-MV-14-T
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Necrosis (1971)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.No contact information was provided for the initial reporter, therefore additional event, product, and/or patient details are not attainable.Reason for reoperation: necrosis.
Event or Problem Description
Allergan aesthetics sales rep reported the following on behalf of hcp following expander placement "mastectomy flap began to necrosis, and suture tabs (3 total) had pulled away from the expander." additionally rep reported "sutures did not pull through the tabs rather the whole tab pulled away from expander." device has been explanted.Unknown side.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: e.3.
Event or Problem Description
Allergan aesthetics sales rep reported the following on behalf of hcp following expander placement "mastectomy flap began to necrosis, and suture tabs (3 total) had pulled away from the expander." additionally rep reported "sutures did not pull through the tabs rather the whole tab pulled away from expander." device has been explanted.Unknown side.

• Brand Name: NATRELLE TE SMOOTH 133S-MV-14-T
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 10359101
• Report Number: 9617229-2020-11850
• Device Sequence Number: 14204400
• Product Code: LCJ
• UDI-Device Identifier: 10888628043886
• UDI-Public: 10888628043886
• Combination Product (Y/N): N
• PMA/510(K) Number: K182054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2020

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: 10/28/2024
• Device Model Number: 133S-MV-14-T
• Device Catalogue Number: 133S-MV-14-T
• Device Lot Number: 3392749
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/07/2020
• Supplement Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 08/03/2020
• Supplement Report FDA Received Date: 12/02/2020
• 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