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

Catalog Number UNK TISSUE EXPANDER

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Foreign Body Sensation in Eye (1869)

Event Type  Injury  

Manufacturer Narrative

A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.¿ device labeling: 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.

Event Description

Healthcare provider reported left side ¿exposed tissue expander.¿ device has been explanted.

• 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: 7620944
• MDR Text Key: 111736013
• Report Number: 9617229-2018-04531
• Device Sequence Number: 1
• Product Code: LCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K862203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• 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: 05/23/2018
• 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