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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 133MX TISSUE EXPANDER WITH SUTURE TAB; EXPANDER, SKIN, INFLATABLE
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ALLERGAN (COSTA RICA) STYLE 133MX TISSUE EXPANDER WITH SUTURE TAB; EXPANDER, SKIN, INFLATABLE Back to Search Results
Model Number 133MX-12-T
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code Failure of Implant (1924)
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.Reason for reoperation: deflation.
 
Event or Problem Description
Patient reported left side "leak".Device has been explanted.
 
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Brand Name
STYLE 133MX 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 Key9891016
Report Number9617229-2020-04884
Device Sequence Number11286241
Product Code LCJ
UDI-Device Identifier10888628004474
UDI-Public10888628004474
Combination Product (Y/N)N
PMA/510(K) Number
K102806
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2016
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? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date05/22/2019
Device Model Number133MX-12-T
Device Catalogue Number133MX-12-T
Device Lot Number2762922
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/26/2020
Initial Report FDA Received Date03/27/2020
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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