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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 133PLUS MX TISSUE EXPANDER WITH SUTURE TAB; EXPANDER, SKIN, INFLATABLE
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ALLERGAN (COSTA RICA) STYLE 133PLUS MX TISSUE EXPANDER WITH SUTURE TAB; EXPANDER, SKIN, INFLATABLE Back to Search Results
Catalog Number 133P-MX-12-T
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.Reason for reoperation: deflation.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
Patient reported left side deflation.Device has been explanted.
 
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Brand Name
STYLE 133PLUS MX 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 Key9444337
Report Number9617229-2019-19630
Device Sequence Number11419718
Product Code LCJ
UDI-Device Identifier10888628010154
UDI-Public10888628010154
Combination Product (Y/N)N
Initial Reporter StateWA
PMA/510(K) Number
K143354
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,consum
Initial Reporter Occupation Other
Type of Report Initial
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 Date04/13/2022
Device Catalogue Number133P-MX-12-T
Device Lot Number3052919
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/12/2019
Initial Report FDA Received Date12/10/2019
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;
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