MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 133MV TISSUE EXPANDER WITH SUTURE TAB; EXPANDER, SKIN, INFLATABLE

Catalog Number	133MV-15-T
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
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.Device labeling: deflation- patients should be advised that the tissue expanders may deflate, and require replacement surgery.Deflation occurs when saline leaks through a damaged injection site or a damaged tissue expander envelope.
Event or Problem Description
Healthcare professional reported an unknown side "leaking" tissue expander.The device has been explanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified yellow particles and fluids clear inside the device.Leak test was performed, and no leakage was found.A microscopic analysis was performed which identified device as intact and functional.Based on the device analysis the final assessment is no issues found related with the manufacturing process, and no openings observed in the device.
Event or Problem Description
Healthcare professional reported a left side "leaking" tissue expander.The device has been explanted.

• Brand Name: STYLE 133MV TISSUE EXPANDER WITH SUTURE TAB
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 7763940
• Report Number: 9617229-2018-05951
• Device Sequence Number: 11070320
• Product Code: LCJ
• UDI-Device Identifier: 10888628004443
• UDI-Public: 10888628004443
• Combination Product (Y/N): N
• Initial Reporter State: PA
• PMA/510(K) Number: K102806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2018

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: 03/21/2022
• Device Catalogue Number: 133MV-15-T
• Device Lot Number: 3191813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Initial Date Received by Manufacturer: 07/11/2018
• Supplement Date Received by Manufacturer: 08/24/2018
• Initial Report FDA Received Date: 08/08/2018
• Supplement Report FDA Received Date: 09/13/2018
• 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