MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 133PLUS MX TISSUE EXPANDER WITH SUTURE TAB; EXPANDER, SKIN, INFLATABLE

Model Number	133P-MX-12-T
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	10/18/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported ¿she has pain all the time and she hasn't slept through the night since they were implanted.She can't lie on her back at all.She said she has shooting pain in her left breast and her right breast looks like three quarters of a breast with a flat bottom.She said her right breast is hard as a rock.She has nipple discharge, breasts look extremely deformed and misshapen to the point they don't even look like breasts; they used to look like breasts but now they look like boxes because the bottoms are completely flat." patient additionally reported "capsular contracture baker grade iv." this record is for the right side.Device remains implanted.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformance's noted.The event of capsular contracture is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.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: capsular contracture baker grade iv, visibility/palpability, nipple discharge, pain.

• Brand Name: STYLE 133PLUS MX TISSUE EXPANDER WITH SUTURE TAB
• 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: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 16263521
• Report Number: 9617229-2023-01711
• Device Sequence Number: 14965821
• Product Code: LCJ
• UDI-Device Identifier: 10888628010154
• UDI-Public: 10888628010154
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 11/02/2021
• Device Model Number: 133P-MX-12-T
• Device Catalogue Number: 133P-MX-12-T
• Device Lot Number: 2993495
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2020
• Initial Report FDA Received Date: 01/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2016
• 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: 48 YR
• Patient Sex: Female