MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE TE SMOOTH 133S-MV-15-T; EXPANDER, SKIN, INFLATABLE

Model Number	133S-MV-15-T
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.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: foreign material on implant.
Event or Problem Description
Healthcare professional reported an implant with "random material stuck on it." device was not implanted.Surgery was completed with a back-up device.
Additional Manufacturer Narrative
Device evaluation: analysis of the returned device identified: white particles outer device and device appearance(a brown particle is observed on the shell with a rough aspect and with a measurement of 6.0mm, it will be sent to analyze) leak test analysis was performed which identified: device no leak.Based on the device analysis the final assessment is: foreign material was observed on the surface of the shell, however external laboratory analyzes concluded that it is not possible to identify the observed particle.Additionally, the external laboratory analysis is attached.Based on the analysis, workmanship is not considered, due to the fact that the device is not received in its original sealed packaging.The external laboratory results were inconclusive due to the size of the particle.
Event or Problem Description
Healthcare professional reported an implant with "random material stuck on it." device was not implanted.Surgery was completed with a back-up device.
Event or Problem Description
Healthcare professional reported an implant with "random material stuck on it." device was not implanted.Surgery was completed with a back-up device.
Additional Manufacturer Narrative
Fi results: sampling test inspection (315 ea) was performed.As per the corresponding procedure, visual and physical inspection were performed, and all components were noted conformant during the testing.4078 ea were released on december 17, 2019.In addition, the primary packaging equipment log was verified and all parameters (temperature-time-pressure) during the primary packaging process met the specifications.See ¿020833 form¿ attached.Review of work order 3413995 and the event "foreign material on implant (particle inside package)" did not identify any ncs or capa associated with this information.
Event or Problem Description
Healthcare professional reported an implant with "random material stuck on it." device was not implanted.Surgery was completed with a back-up device.

• Brand Name: NATRELLE TE SMOOTH 133S-MV-15-T
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• MDR Report Key: 11446541
• Report Number: 9617229-2021-02673
• Device Sequence Number: 3105807
• Product Code: LCJ
• UDI-Device Identifier: 10888628043893
• UDI-Public: 10888628043893
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/10/2025
• Device Model Number: 133S-MV-15-T
• Device Catalogue Number: 133S-MV-15-T
• Device Lot Number: 3413995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 03/16/2021; 05/24/2021; 07/07/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 04/13/2021; 06/21/2021; 08/05/2021
• 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