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

Catalog Number J133SX-16

Device Problem No Apparent Adverse Event (3189)

Patient Problem Abscess (1690)

Event Date 03/10/2018

Event Type  Injury  

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformances noted.The event of abscess is considered a physiological complaint, and analysis of the device generally does not assist allergan in determining a probable cause for these events.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.

Event Description

Healthcare professional reported left side "post operative wound infection" and "abscess." treatment of "incision of an abscess, pus discharge," and "washing capsule" were provided, and the device was explanted.

• Brand Name: STYLE 133SX 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: 7418642
• MDR Text Key: 105120866
• Report Number: 9617229-2018-02741
• Device Sequence Number: 1
• Product Code: LCJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K862203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2019
• Device Catalogue Number: J133SX-16
• Device Lot Number: 2979468
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2016
• 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