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

Model Number	133S-MX-15-T
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/14/2020
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.
Event or Problem Description
Healthcare professional reported a tissue expander that "did not have an inner sterile wrapping." device was not implanted.
Event or Problem Description
Healthcare professional reported a tissue expander that "did not have an inner sterile wrapping." device was not implanted and was discarded.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.Further investigation results: according to the information gathered during the investigation, there was enough evidence to support that the devices was assembled in accordance with allergan medical procedures and specifications.The reported device was intact at the time of production and met the required specifications.The device has not been retuned to be analyzed in the laboratory.A review of the current risk documents was performed and the event of ¿breach of sterile barrier seal" was a known event, for which manufacturing process controls and inspections are stablished to reduce the incidence of this defect.Considering that there is no adverse trend for this type of event, no additional actions are deemed required at this time.The issue with "breach of sterile barrier seal in the valve" will continue to be monitored and corrective actions will be taken in the future if deemed appropriate.

• Brand Name: NATRELLE TE SMOOTH 133S-MX-15-T
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 10837306
• Report Number: 9617229-2020-18750
• Device Sequence Number: 19708369
• Product Code: LCJ
• UDI-Device Identifier: 10888628044210
• UDI-Public: 10888628044210
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 12/17/2020

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: 09/17/2024
• Device Model Number: 133S-MX-15-T
• Device Catalogue Number: 133S-MX-15-T
• Device Lot Number: 3381271
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/16/2020
• Supplement Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 12/17/2020
• 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