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 Abscess (1690); Capsular Contracture (1761); Seroma (2069)

Event Date 05/04/2019

Event Type  Injury  

Manufacturer Narrative

Article citation: atkins, katelyn m., et al.¿effects of postmastectomy radiation therapy on immediate tissue expander and acellular dermal matrix reconstruction: results of a prospective clinical trial.¿ practical radiation oncology, 2019, doi:10.1016/j.Prro.2019.04.009.(b)(4).The events of capsular contracture, seroma, abscess, wound dehiscence, ischemia, drainage, delayed healing, and infection are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Reason for reoperation: mastectomy.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.This is a known potential adverse event addressed in the product labeling.[(b)(4)].

Event Description

Reviewed and attached journal article "effects of post-mastectomy radiation therapy on immediate tissue expander and acellular dermal matrix reconstruction: results of a prospective clinical trial." per the journal article the events of "delayed healing, dehiscence, infection, abscess, skin ischemia, seroma, chronic drainage, pain, deflation," and "capsular contracture," baker grade unknown were reported against an unknown side tissue expander.Device status is 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: michelle burgess ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 8696348
• MDR Text Key: 147912833
• Report Number: 9617229-2019-06193
• Device Sequence Number: 1
• Product Code: LCJ
• Combination Product (y/n): N
• PMA/PMN Number: K862203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• 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: 05/15/2019
• 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