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

Catalog Number N-SZLF390

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

Patient Problem Failure of Implant (1924)

Event Date 11/27/2015

Event Type  malfunction  

Manufacturer Narrative

The initial mdr decision on this complaint deemed this event not reportable.However, upon review, it was deemed a reportable malfunction and is being reported late.This deviation has been captured in investigation capa (b)(4).To date, no clarification has been received to confirm whether this device had been re-sterilized by the healthcare professional or was directly out of box.Device labeling addresses: "preliminary product examination: prior to use, examine the re-sterilizable sizer for any evidence of damage or particulate contamination.Do not use damaged or contaminated re-sterilizable sizers." reviewed device history record: 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 saline 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.In addition, dhr for shell runs number (b)(4) did not identify any deviations, errors, omissions or non-conformances that may be associated with the reported device event.All shells were reviewed as part of the shell fabrication operations and these tasks were performed according to applicable current procedures to ensure that fabrication met the required specifications.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.

Event Description

Pharmacist reports: "fine particle plastic (diameter 1.5 cm) transparent (cellophane type) on sizers for anatomic implants (not for sizers for round implants).The sizers were therefore washed and still used to allow the installation of prosthesis, surgeons were notified of the defect and clean the sizers to avoid leaving particles 'inside the patient'." back-up device was not used as the physician "washed and still used" the device.

Manufacturer Narrative

Device is not available for analysis and therefore, the reported "particle plastic" present on the device cannot be confirmed by allergan.Review of device history record confirmed no identification of any deviations, errors, omissions or non-conformances that may be associated with the reported device 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.Mfr # 9617229-2015-00594 captures an additional device used on this patient during the same surgery with the same reported event.

Event Description

Per follow-up, physician reported, "the sizers have not been re-sterilized before use, the nurses simply removed the particles and cleaned the prosthesis.Devices have been kept as usual in our institution: ambient temperature, in their initial packaging (packaging allergan).The implants are never to be opened before surgery.Its only when the physician decides which implant will be implanted that they are taken out of the allergan boxes.I really don't think that the particles could provide from the environment they were kept, because we didn't came across similar case since this report." further clarification was received to confirm that the sizer had not been used before, had not been previously sterilized, and was removed directly from the allergan packaging.The particles were noticed when the sizer was removed from the packaging.

• Brand Name: STYLE 410 LF 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: 5585561
• MDR Text Key: 42942557
• Report Number: 9617229-2015-00595
• 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: foreign,health professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: N-SZLF390
• Device Lot Number: 2700060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2015
• Is the Device Single Use?: No
• 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: 48 YR