MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) UNK SIZER (RESTERILIZABLE); SIZER, MAMMARY, BREAST IMPLANT VOLUME

Catalog Number UNK SIZER (RESTERILIZABLE)

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Reason for reoperation reported as "implant has to be removed because damaged." additionally, a "sizer" was noted to be the device implanted, use error.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

Physician reported side unspecified "implant has to be removed because damaged." additionally, a "sizer" was noted implanted beyond the recommended period for expansion.The device has been explanted.

• Brand Name: UNK SIZER (RESTERILIZABLE)
• Type of Device: SIZER, MAMMARY, BREAST IMPLANT VOLUME
• 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: 8679969
• MDR Text Key: 147365074
• Report Number: 9617229-2019-05952
• Device Sequence Number: 1
• Product Code: MRD
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K831566
• 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: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SIZER (RESTERILIZABLE)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2019
• 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): Other; Required Intervention
• Patient Age: 38 YR