MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE TE SMOOTH 133S-FX-13-T; EXPANDER, SKIN, INFLATABLE

Model Number	133S-FX-13-T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/19/2020
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.Device evaluation: visual analysis of the returned device identified broken shell.Leak test and microscopic analysis were performed which identified a broken striated edge on suture tab and striated opening on anterior.Based on the device analysis the final assessment was a striated opening on anterior assessed as surgical damage consistent in the use of some surgical tools, and a broken striated edge on suture tab assessed as surgical damage consist in the use of some surgical tools.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: broken device.
Event or Problem Description
Healthcare professional reported right side "had a small hole in it.¿ device was not implanted.

• Brand Name: NATRELLE TE SMOOTH 133S-FX-13-T
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 11057414
• Report Number: 9617229-2020-21575
• Device Sequence Number: 16815503
• Product Code: LCJ
• UDI-Device Identifier: 10888628044036
• UDI-Public: 10888628044036
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Report Date (Section B): 12/22/2020

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: 11/04/2024
• Device Model Number: 133S-FX-13-T
• Device Catalogue Number: 133S-FX-13-T
• Device Lot Number: 3393076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 12/22/2020
• 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