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

Catalog Number	133MV-12-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.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Healthcare provider reported left side "failed to hold the volume of saline, a suspected a leak, device migration, and significant disabling pain on lateral left side." expansion was not completed.Device has been explanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified: white encapsulation and more than 3 openings.Leak test and microscopic analysis was performed which identified: more than 3 striated openings.
Event or Problem Description
Healthcare provider reported left side "failed to hold the volume of saline, a suspected a leak, device migration, and significant disabling pain on lateral left side." expansion was not completed.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: 8286748
• Report Number: 9617229-2019-00267
• Device Sequence Number: 2056310
• Product Code: LCJ
• UDI-Device Identifier: 10888628004412
• UDI-Public: 10888628004412
• Combination Product (Y/N): N
• Initial Reporter State: FL
• PMA/510(K) Number: K102806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2019

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: 02/13/2021
• Device Catalogue Number: 133MV-12-T
• Device Lot Number: 3030369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Initial Date Received by Manufacturer: 01/07/2019
• Supplement Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 01/29/2019
• Supplement Report FDA Received Date: 02/21/2019
• 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