MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE TE SMOOTH 133S-MX-12-T; EXPANDER, SKIN, INFLATABLE

Model Number	133S-MX-12-T
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.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: not applicable as the device was not implanted.
Event or Problem Description
Healthcare professional reported "small piece of a metallic foreign body on the inferior aspect of the tissue expander just off from midline" and "another foreign body noted which was clear and had a bristle-like filamentous appearance" with a "static charge" on a tissue expander that was not implanted.Patient contact did not occur.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: h6.A further investigation has been completed and is consistent with the record.Review of dhr for work order 3392769 did not identify any deviations, errors, omissions or non-conformances that may be associated with the reported device event.All tissue expander 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 or Problem Description
Healthcare professional reported "small piece of a metallic foreign body on the inferior aspect of the tissue expander just off from midline" and "another foreign body noted which was clear and had a bristle-like filamentous appearance" with a "static charge" on a tissue expander that was not implanted.Patient contact did not occur.
Event or Problem Description
Healthcare professional reported "small piece of a metallic foreign body on the inferior aspect of the tissue expander just off from midline" and "another foreign body noted which was clear and had a bristle-like filamentous appearance" with a "static charge" on a tissue expander that was not implanted.Patient contact did not occur.
Additional Manufacturer Narrative
Photo analysis: visual analysis of the photographs identified black and orange particles were observed however this material cannot be measured and inspected because it was not sent to dal and either it is not possible to assess the device as workmanship.This case is assessed as possibly workmanship related, any observations which may be unacceptable per quality assurance inspection procedure (s) but cannot be verified by laboratory personnel to have been definitely caused by an error in device manufacturing/packaging.A further investigation was requested to determine if there this defect could be related to the manufacturing/packaging process.Based on the device analysis the final assessment is: observed a foreign material which could not be assessed as workmanship due to the lack of the physical device.Additional, changed, and/or corrected data: h.6 allergan did not submit this mdr within 30 days of becoming aware.Recent stimulated reporting related to 2011068-7/2/19-001-r has increased complaint and mdr volume.Allergan is implementing a plan to address the increased volumes.

• Brand Name: NATRELLE TE SMOOTH 133S-MX-12-T
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 9981125
• Report Number: 9617229-2020-06771
• Device Sequence Number: 3896592
• Product Code: LCJ
• UDI-Device Identifier: 10888628044180
• UDI-Public: 10888628044180
• Combination Product (Y/N): N
• Initial Reporter State: MI
• PMA/510(K) Number: K182054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/22/2024
• Device Model Number: 133S-MX-12-T
• Device Catalogue Number: 133S-MX-12-T
• Device Lot Number: 3392769
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/30/2020
• Supplement Date Received by Manufacturer: 06/08/2020; 05/17/2021
• Initial Report FDA Received Date: 04/21/2020
• Supplement Report FDA Received Date: 04/06/2021; 06/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other