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

Catalog Number UNK STYLE 133

Device Problems Fluid/Blood Leak (1250); Patient-Device Incompatibility (2682)

Patient Problems Unspecified Infection (1930); Seroma (2069); Skin Inflammation (2443)

Event Type  Injury  

Manufacturer Narrative

Article citation: e.Riggio, e.Toffoli and c.Tartaglione et al., "local safety of immediate reconstruction during primary treatment of breast cancer.Direct-to-implant versus expander-based surgery." journal of plastic, reconstructive & aesthetic surgery, https://doi.Org/10.1016/j.Bjps.2018.10.016.(b)(4).The event of infection (unknown onset), inflammation/irritation, exposure, deflation, seroma, and necrosis are physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.These events are known potential adverse events addressed in the product labeling.

Event Description

Through journal article 'local safety of immediate reconstruction during primary treatment of breast cancer.Direct-to-implant versus expander-based surgery' the following complications, which did not necessitate revision surgery, were reported: infection, seroma, wound dehiscence, stretched skin and scar tension, pain in axillary and dorsal regions, skin necrosis, skin inflammation, hematoma and expander displacement (lateral).And the following complications, which did necessitate revision surgery, were reported: infection, skin inflammation, "cxposure" of tissue expander, breakage / damage of tissue expander, recurrent seroma, skin necrosis and severe lateral displacement of expander.No further treatment information or affected side were provided.Device status is currently unknown.

• Brand Name: STYLE 133 TISSUE EXPANDER
• Type of Device: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer Contact: suzanne wojcik ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 8199540
• MDR Text Key: 131504739
• Report Number: 9617229-2018-09921
• Device Sequence Number: 1
• Product Code: LCJ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K862203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK STYLE 133
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention