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

Model Number	133MV-12-T
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information regarding the event, product, or patient details has been requested from the reporter; no additional information is available at this time.A review of the device history record has been completed.No deviations or non-conformances noted.Device labeling: the following is a list of potential adverse events that may occur with breast implant surgery.The risks include: implant deflation/leakage, additional surgery, capsular contracture, infection, toxic shock syndrome, necrosis, hematoma, seroma, extrusion, breast pain, changes in nipple sensation, changes in breast sensation, dissatisfaction with cosmetic results (wrinkling, folding, displacement, asymmetry, palpability, visibility, ptosis, sloshing), calcific deposits, irritation/inflammation, delayed wound healing, hypertrophic scarring, breast tissue atrophy/chest wall deformity, difficulty/inability in breast feeding, and inability to adequately visualize breast lesions with mammography.In addition to these potential adverse events, there have been concerns with certain systemic diseases.Deflation - patients should be advised that the tissue expanders may deflate, and require replacement surgery.Deflation occurs when saline leaks through a damaged injection site or a damaged tissue expander envelope.Premature explantation - adverse reactions may require premature explantation.
Event or Problem Description
Patient reported deflation of a tissue expander on an unknown side.Device has been explanted.

• Brand Name: STYLE 133MV TISSUE EXPANDER WITH SUTURE TAB
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 6826816
• Report Number: 9617229-2017-01539
• Device Sequence Number: 1118168
• Product Code: LCJ
• UDI-Device Identifier: 10888628004412
• UDI-Public: (01)10888628004412(10)2917492(11)160531(17)200430
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K102806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/29/2017

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: 04/30/2020
• Device Model Number: 133MV-12-T
• Device Catalogue Number: 133MV-12-T
• Device Lot Number: 2917492
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2017
• Initial Report FDA Received Date: 08/29/2017
• 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