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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 133SX TISSUE EXPANDER; EXPANDER, SKIN, INFLATABLE
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ALLERGAN (COSTA RICA) STYLE 133SX TISSUE EXPANDER; EXPANDER, SKIN, INFLATABLE Back to Search Results
Catalog Number 133SX-13
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 01/05/2019
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.This is a known potential adverse event addressed in the product labeling.
 
Event or Problem Description
Patient reported a right side deflation.Expander was implanted for more than 6 months.Device remains implanted.
 
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Brand Name
STYLE 133SX TISSUE EXPANDER
Common Device Name
EXPANDER, SKIN, INFLATABLE
Manufacturer (Section D)
ALLERGAN (COSTA RICA)
900 parkway global park
zona franca
CS 
MDR Report Key8287447
Report Number9617229-2019-00258
Device Sequence Number11276773
Product Code LCJ
UDI-Device Identifier10888628003828
UDI-Public10888628003828
Combination Product (Y/N)N
PMA/510(K) Number
K862203
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 01/29/2019
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 Date07/22/2021
Device Catalogue Number133SX-13
Device Lot Number3093426
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/08/2019
Initial Report FDA Received Date01/29/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age36 YR
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