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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 133 TISSUE EXPANDER; EXPANDER, SKIN, INFLATABLE
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ALLERGAN (COSTA RICA) STYLE 133 TISSUE EXPANDER; EXPANDER, SKIN, INFLATABLE Back to Search Results
Catalog Number UNK STYLE 133
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Capsular Contracture (1761); Pocket Erosion (2013)
Event Type  Injury  
Manufacturer Narrative
The reason for reoperation is capsular contracture, baker grade iv.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The event of capsular contracture is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.This is a known adverse event addressed in the labeling.
 
Event Description
Patient reported "i currently have a grade 4 capsular constriction on left side and they.Causing pain and distortion" and "limited arm movement." the device remains implanted.
 
Event Description
Patient reported "expanders was penetrating skin", "pain to chest, rash, breast swelling and distortion to breast".The device has been explanted.
 
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Brand Name
STYLE 133 TISSUE EXPANDER
Type of Device
EXPANDER, SKIN, INFLATABLE
Manufacturer (Section D)
ALLERGAN (COSTA RICA)
900 parkway global park
zona franca
CS 
MDR Report Key8573167
MDR Text Key143820188
Report Number9617229-2019-03108
Device Sequence Number1
Product Code LCJ
Combination Product (y/n)N
PMA/PMN Number
K862203
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,other
Type of Report Initial,Followup
Report Date 07/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK STYLE 133
Was Device Available for Evaluation? No
Date Manufacturer Received07/01/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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