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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 133PLUS FV TISSUE EXPANDER; EXPANDER, SKIN, INFLATABLE
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ALLERGAN (COSTA RICA) STYLE 133PLUS FV TISSUE EXPANDER; EXPANDER, SKIN, INFLATABLE Back to Search Results
Catalog Number 133P-FV-13
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 the events, product, and patient details have 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
Healthcare professional reported left side deflation of a tissue expander implanted over 6 months prior.The device remains implanted.
 
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Brand Name
STYLE 133PLUS FV TISSUE EXPANDER
Common Device Name
EXPANDER, SKIN, INFLATABLE
Manufacturer (Section D)
ALLERGAN (COSTA RICA)
900 parkway global park
zona franca
CS 
MDR Report Key8202774
Report Number9617229-2018-09783
Device Sequence Number11180065
Product Code LCJ
UDI-Device Identifier10888628009684
UDI-Public10888628009684
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K143354
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/28/2018
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 Date07/31/2021
Device Catalogue Number133P-FV-13
Device Lot Number2954464
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/10/2018
Initial Report FDA Received Date12/28/2018
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;
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