MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 410 MM RE-STERILIZABLE SIZER; SIZER, MAMMARY, BREAST IMPLANT VOLUME

Catalog Number N-SZMM360

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Not Applicable (3189)

Event Date 02/01/2017

Event Type  malfunction  

Manufacturer Narrative

It was not possible to fully investigate or confirm the alleged event as the product was not returned to allergan for analysis.Follow-up will be performed to request device return.If device is returned, it will be analyzed and results sent to the fda in a supplemental report.Device history record results: review of dhr for work order (b)(4) did not identify any errors, omissions or non-conformances that may be associated with the reported device event.All re-sterilizable sizers 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.Deviation number (b)(4) was referenced in dhr record for work order (b)(4); this deviation is related to an incorrect weight registry, however there is no impact to the devices as this work order was not related to the deviation and it was associated only as a containment measure.Additionally all the order weight were checked an confirmed to be within specifications also, these defects have no relation with the reported event.The dhr assembly report from sap was verified and three devices were scrapped during the assembly process (1 at, 1 dc, 1 fi) which are not related to the reported event.According to the information gathered during the dhr review, there is enough evidence to support that devices from work order (b)(4) were assembled in accordance with allergan medical procedures and specifications.The reported device was intact at the time of production and met the required specifications.Device labeling: each sizer is supplied sterile in a sealed, double package.Sterility of the sizer is maintained only if the packages, including the package seals, are intact.Do not use the product if the packages or seals have been damaged.

Event Description

Physician reports they opened a new sizer pack and found a foreign body in the package, looking like a piece of cling wrap.The device was not implanted.

Manufacturer Narrative

Results of device analysis: visual analysis of the returned device identified: fold creases, weight measurement within specification, white and brown particles on shell surface, and also identified a particle with the following characteristics: transparent color, measured 3.0 cm approximately, irregular shape and smooth type.Additional visual analysis identified bubbles on gel (after autoclave cycle) and a particle above the specification according to qa199.12.(specification: no particle greater than (>) 1mm inside package.) based on the device analysis, the final assessment is: a particle found above the nominal specification.Device history record was raised due to particle observed above specification: review of dhr for this work order did not identify any deviations, errors, omissions or non-conformances during manufacturing process.All re-sterilizable sizer 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.Counter measure for ncmr number (b)(4) was referenced in dhr record for work order number (b)(4); this counter measure is related to primary package weight process.Also, these counter measure have no relation with the reported event.The dhr assembly report from sap was verified and 3 device were scrapped during the assembly process (1at, 1dc, 1fi) which are not related to the reported event.Further investigation was raised due to particle observed above specification: according to the information gathered during the investigation, there is enough evidence to support that devices from work order (b)(4) were assembled in accordance with allergan medical procedures and specifications.The reported device was intact at the time of production and met the required specifications.During the device analysis it was observed like a piece of plastic on shell surface, it is out of specification according to (b)(4).Considering that there is not an adverse trend for this type of event no additional actions are deemed required at this time.The issue with foreign material on implant will continue to be monitored and corrective action taken in the future if deemed appropriate.

Event Description

Physician reports they opened a new sizer pack and found a foreign body in the package, looking like a piece of cling wrap.The device was not implanted.

• Brand Name: STYLE 410 MM RE-STERILIZABLE SIZER
• 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: 6352640
• MDR Text Key: 68123023
• Report Number: 9617229-2017-00112
• Device Sequence Number: 1
• Product Code: MRD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K831566
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2021
• Device Catalogue Number: N-SZMM360
• Device Lot Number: 2985252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2016
• 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