MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 133MV TISSUE EXPANDER; EXPANDER, SKIN, INFLATABLE

Model Number	133MV-12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/03/2018
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.The event of "infection (unknown onset)" is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Further information cannot be requested as contact information has not been provided reason for reoperation: infection (unknown onset), pain, visibility/palpability, inflammation/irritation, sensation increase/decrease, anxiety-product/procedure, varied injuries-ndr.
Event or Problem Description
Patient representative reported "if patient knew of the significant potential health risks of allergan¿s natrelle style 410 fx implants, they would never have had allergan¿s biocell product implanted in their body.As a result of the implantation of allergan¿s defective natrelle style 410 fx implant, patient has suffered physical complaints and symptoms, all of which are causally connected to allergan¿s natrelle style 410 fx implant.Patient has experienced pain under their armpits, under and across chest, backpain, pain when taking deep breaths.Difficulty with sexual activity, numbness, stiffness, pulling, aching, shooting pain into the armpits, shoulder pain ,neck pain, tingling and numbness in arms, hands, fingers, loss of strength in arms and hands, dental issues, musculo skeletal complaints, redness, swelling, shoulder pain, stiffness.Formation of scars around the incision, nerve, back and neck pain, divots, soreness, fever, infection and discomfort.Patient also suffered from and presently suffers great fear that allergan¿s recalled and defective natrelle style 410 fx implant will result in them experiencing bia-alcl and/or death." the device has been explanted.This record is for the left side.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.
Event or Problem Description
Patient representative reported "if patient knew of the significant potential health risks of allergan¿s natrelle style 410 fx implants, they would never have had allergan¿s biocell product implanted in their body.As a result of the implantation of allergan¿s defective natrelle style 410 fx implant, patient has suffered physical complaints and symptoms, all of which are causally connected to allergan¿s natrelle style 410 fx implant.Patient has experienced pain under their armpits, under and across chest, backpain, pain when taking deep breaths.Difficulty with sexual activity, numbness, stiffness, pulling, aching, shooting pain into the armpits, shoulder pain ,neck pain, tingling and numbness in arms, hands, fingers, loss of strength in arms and hands, dental issues, musculo skeletal complaints, redness, swelling, shoulder pain, stiffness.Formation of scars around the incision, nerve, back and neck pain, divots, soreness, fever, infection and discomfort.Patient also suffered from and presently suffers great fear that allergan¿s recalled and defective natrelle style 410 fx implant will result in them experiencing bia-alcl and/or death." the device has been explanted.This record is for the left side.

• Brand Name: STYLE 133MV TISSUE EXPANDER
• 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: 12590683
• Report Number: 9617229-2021-53301
• Device Sequence Number: 3289347
• Product Code: LCJ
• UDI-Device Identifier: 10888628004115
• UDI-Public: 10888628004115
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K862203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2022

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: 08/20/2020
• Device Model Number: 133MV-12
• Device Catalogue Number: 133MV-12
• Device Lot Number: 2960838
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/09/2020
• Supplement Date Received by Manufacturer: 11/06/2021
• Initial Report FDA Received Date: 10/07/2021
• Supplement Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2016
• 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 Age: 52 YR
• Patient Sex: Female