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

Model Number	133S-FV-13-T
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/15/2021
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: left side deflation of a tissue expander due to one of the tabs breaking off.
Event or Problem Description
Healthcare professional reported left side deflation of a tissue expander due to one of the tabs breaking off.Device has been explanted.
Event or Problem Description
Healthcare professional reported, left side deflation of a tissue expander, due to one of the tabs breaking off.Device has been explanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified, curved opening, around 75-100% of the suture tap is missing, delamination of suture tap, yellow particles in shell.The leak test and microscopic analysis was performed which identified, curved striated openings on anterior side assessed, as surgical damage.Curved sharp openings on suture taps assessed, as unidentified (tear) opening.(a dimension measurement in the shell was performed which identify, the thickness within specification).Partial delamination of suture tap assessed, as adhesive failure.

• Brand Name: NATRELLE TE SMOOTH 133S-FV-13-T
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• MDR Report Key: 12203688
• Report Number: 9617229-2021-47350
• Device Sequence Number: 16474554
• Product Code: LCJ
• UDI-Device Identifier: 10888628043794
• UDI-Public: 10888628043794
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K182054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/25/2025
• Device Model Number: 133S-FV-13-T
• Device Catalogue Number: 133S-FV-13-T
• Device Lot Number: 3417904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 09/15/2021
• 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: Required Intervention
• Patient Age: 44 YR
• Patient Weight: 74