MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE INSPIRA MODPROF 375CC SIZER US; SIZER, MAMMARY, BREAST IMPLANT VOLUME

Catalog Number MSZ-M375

Device Problem No Apparent Adverse Event (3189)

Patient Problem Local Reaction (2035)

Event Date 04/14/2016

Event Type  Injury  

Manufacturer Narrative

Device evaluation showed the device weighed 378.57 gm.White particles were observed on the shell of the implant.One striated opening, consistent with surgical damage, was located 5 cm away from the center patch on the posterior portion of the implant.The event of allergic reaction is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Review of dhr for work order (b)(4) did not identify any deviations, errors, omissions or non-conformances that may be associated with the reported device event.All gel breast implants were reviewed as part of the assembly operations and these tasks were performed according to applicable current procedures to ensure that assembly met the required specifications.

Event Description

Healthcare professional reported upon placing the sizer on the right side, the patient began having an immediate allergic reaction to the device.

Manufacturer Narrative

Medwatch submitted on 05/25/2016.

Event Description

Healthcare professional reported upon placing the sizer on the right side, the patient began having an immediate allergic reaction to the device.

• Brand Name: NATRELLE INSPIRA MODPROF 375CC SIZER US
• 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: suzanne wojcik ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 5662693
• MDR Text Key: 45404614
• Report Number: 9617229-2016-00048
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/17/2020
• Device Catalogue Number: MSZ-M375
• Device Lot Number: 2776764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2015
• 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
• Patient Age: 41 YR