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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 133FX TISSUE EXPANDER WITH SUTURE TAB; EXPANDER, SKIN, INFLATABLE
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ALLERGAN (COSTA RICA) STYLE 133FX TISSUE EXPANDER WITH SUTURE TAB; EXPANDER, SKIN, INFLATABLE Back to Search Results
Model Number 133FX-12-T
Medical Device Problem Code Patient-Device Incompatibility (2682)
Health Effect - Clinical Code Injury (2348)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.The event of exposure is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.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: exposure.
 
Event or Problem Description
Healthcare professional reported left side exposure.Device has been explanted.
 
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Brand Name
STYLE 133FX 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 Key9647640
Report Number9617229-2020-00916
Device Sequence Number11556224
Product Code LCJ
UDI-Device Identifier10888628004290
UDI-Public10888628004290
Combination Product (Y/N)N
Initial Reporter StateIA
PMA/510(K) Number
K102806
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
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 Date11/08/2020
Device Model Number133FX-12-T
Device Catalogue Number133FX-12-T
Device Lot Number2996267
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/07/2020
Initial Report FDA Received Date01/30/2020
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 Required Intervention;
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