MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 133FV TISSUE EXPANDER; EXPANDER, SKIN, INFLATABLE

Catalog Number	133FV-14
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/30/2018
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.
Event or Problem Description
Physician reported "while filling up the te with solution, it was leaking from a hole on the other side.".
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified: two openings curved on anterior, one opening curved in the patch and clear fluids inside the device.Leak test and microscopic analysis was performed which identified: two openings punctured curved on anterior and one striated opening in the patch.Based on the device analysis the final assessment is: punctured openings on anterior due to surgical damage like.One striated opening due to surgical damage consist in the use of some surgical tool.
Event or Problem Description
Physician reported "while filling up the te with solution, it was leaking from a hole on the other side.".

• Brand Name: STYLE 133FV TISSUE EXPANDER
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 7633826
• Report Number: 9617229-2018-04959
• Device Sequence Number: 19271164
• Product Code: LCJ
• UDI-Device Identifier: 10888628003958
• UDI-Public: 10888628003958
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K862203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

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: 05/26/2021
• Device Catalogue Number: 133FV-14
• Device Lot Number: 3069577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2018
• Initial Date Received by Manufacturer: 05/31/2018
• Supplement Date Received by Manufacturer: 07/21/2018
• Initial Report FDA Received Date: 06/25/2018
• Supplement Report FDA Received Date: 08/14/2018
• 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