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

Catalog Number UNK TISSUE EXPANDER

Device Problems Patient-Device Incompatibility (2682); Appropriate Term/Code Not Available (3191)

Patient Problems Foreign Body Sensation in Eye (1869); Necrosis (1971)

Event Type  Injury  

Manufacturer Narrative

This event is a known potential adverse event addressed in both saline and silicone labeling.As it is unknown whether the affected device is saline or silicone, no device labeling can be sent at this time.The event of necrosis is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.

Event Description

Healthcare professional reported necrosis to the right side.Device remains implanted.

Event Description

Healthcare professional additionally reported the tissue was "wearing so thin that you could see the [product]".

• Brand Name: UNK 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: 8045742
• MDR Text Key: 126368782
• Report Number: 9617229-2018-08486
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK TISSUE EXPANDER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2018
• 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