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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 133PLUS MV TISSUE EXPANDER WITH SUTURE TAB; EXPANDER, SKIN, INFLATABLE
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ALLERGAN (COSTA RICA) STYLE 133PLUS MV TISSUE EXPANDER WITH SUTURE TAB; EXPANDER, SKIN, INFLATABLE Back to Search Results
Catalog Number 133P-MV-14-T
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 02/12/2018
Type of Reportable Event Malfunction
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
Health professional reported "defective expander would not retain saline upon filling." device was not implanted.
 
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Brand Name
STYLE 133PLUS MV 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 Key7324298
Report Number9617229-2018-01829
Device Sequence Number110266
Product Code LCJ
UDI-Device Identifier10888628010079
UDI-Public10888628010079
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K143354
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/08/2018
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 Date04/30/2022
Device Catalogue Number133P-MV-14-T
Device Lot Number3061061
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/12/2018
Initial Report FDA Received Date03/08/2018
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 Other;
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