MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) UNK SIZER - GEL (RESTERILIZABLE); INVASIVE BREAST IMPLANT SIZER, REUSABLE

Catalog Number UNK SIZER-GEL (RESTERILIZABLE)

Device Problems Burst Container or Vessel (1074); Improper or Incorrect Procedure or Method (2017)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Reason for reoperation: burned with contents gel sizer while handling.

Event Description

Healthcare professional reported patient was burned with gel sizer after the physician ¿squeezed it¿ causing ¿the hot gel inside to be pushed to the surface and burned the patient.¿ device status is unknown.

• Brand Name: UNK SIZER - GEL (RESTERILIZABLE)
• Type of Device: INVASIVE BREAST IMPLANT SIZER, REUSABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; la aurora de heredia 74370 ; CS 74370
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park zona f; la aurora de heredia ; CS
• Manufacturer Contact: chris sprague ; 12331-a riata trace parkway; austin, TX 78727 ; 8479375615
• MDR Report Key: 11898516
• MDR Text Key: 253162100
• Report Number: 9617229-2021-16687
• Device Sequence Number: 1
• Product Code: MRD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K831566
• 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
• Report Date: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SIZER-GEL (RESTERILIZABLE)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2021
• 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