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

Catalog Number	133SX-15-T
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/05/2018
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.Device labeling: research continues to address the various hypothetical long-term effects of silicone implants, primarily silicone-filled breast implants.To the extent that such research applies to the safety of silicone in general for implantation, it is relevant to tissue expanders.However, given the intended temporary use of tissue expanders, and the fact that tissue expanders consist primarily of a silicone elastomer shell filled with sterile saline for injection, the research has not been directly concerned with tissue expander use.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 a "rupture" to an unknown side.

• Brand Name: STYLE 133SX 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: 8103245
• Report Number: 9617229-2018-08915
• Device Sequence Number: 16444853
• Product Code: LCJ
• UDI-Device Identifier: 10888628004627
• UDI-Public: 10888628004627
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• PMA/510(K) Number: K102806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/26/2018

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: 09/06/2021
• Device Catalogue Number: 133SX-15-T
• Device Lot Number: 3113286
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2018
• Initial Report FDA Received Date: 11/26/2018
• 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