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

Catalog Number 133MV-13

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Capsular Contracture (1761)

Event Date 07/25/2019

Event Type  Injury  

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformances noted.The event of capsular contracture is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Reason for reoperation due to capsular contracture, baker grade unknown.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.

Event Description

Healthcare professional reported right side capsular contracture, baker grade unknown and the device being implanted for more than 6 months.Device has been explanted.

Event Description

Healthcare professional reported right side capsular contracture, baker grade unknown and the device being implanted for more than 6 months.Device has been explanted.

Manufacturer Narrative

Device evaluation: analysis of the returned device identified yellow biological tissue.Leak test and microscopic analysis was performed which identified: no leakage and crease flat.Based on the device analysis the final assessment is: no issues found related with the manufacturing process.

• Brand Name: STYLE 133MV TISSUE EXPANDER
• Type of Device: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 8958277
• MDR Text Key: 156388266
• Report Number: 9617229-2019-12320
• Device Sequence Number: 1
• Product Code: LCJ
• UDI-Device Identifier: 10888628004122
• UDI-Public: 10888628004122
• 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
• Type of Report: Initial,Followup
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/04/2021
• Device Catalogue Number: 133MV-13
• Device Lot Number: 3072239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Date Manufacturer Received: 10/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR