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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 133MV TISSUE EXPANDER; EXPANDER, SKIN, INFLATABLE
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ALLERGAN (COSTA RICA) STYLE 133MV TISSUE EXPANDER; EXPANDER, SKIN, INFLATABLE Back to Search Results
Catalog Number N-67-133MV13
Device Problems Fluid/Blood Leak (1250); Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)
Patient Problem Capsular Contracture (1761)
Event Date 10/07/2019
Event Type  Injury  
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 "capsular contracture" is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Reason for reoperation: "rupture of expander 11 months after breast reconstruction.Severe encapsulation, velcro look.".
 
Event Description
Healthcare professional reports left side "rupture of expander 11 months after breast reconstruction.Severe encapsulation, velcro look¿.Device was explanted and replaced with another manufacturer's product.
 
Manufacturer Narrative
Device evaluation: a visual analysis of the returned device identified an opening on the radius and anterior of the shell.A leak test was performed and confirmed the openings on the anterior and radius.A microscopic analysis was performed which identified sharp edged opening on anterior of the shell.Also under microscopic analysis, a striated edge opening was identified on radius of the shell, consist with use of a surgical tool.Based on the device analysis the final assessment is: one sharp-edged opening on the anterior due to an unidentified (tear) opening.One striated edge opening on radius assessed as surgical damage.
 
Event Description
Healthcare professional reports left side "rupture of expander 11 months after breast reconstruction.Severe encapsulation, velcro look¿.Device was explanted and replaced with another manufacturer's product.
 
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Brand Name
STYLE 133MV TISSUE EXPANDER
Type of Device
EXPANDER, SKIN, INFLATABLE
Manufacturer (Section D)
ALLERGAN (COSTA RICA)
900 parkway global park
zona franca
CS 
MDR Report Key9511245
MDR Text Key173326249
Report Number9617229-2019-22753
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 company representative,distri
Type of Report Initial,Followup
Report Date 03/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date06/20/2022
Device Catalogue NumberN-67-133MV13
Device Lot Number3069614
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/20/2020
Date Manufacturer Received02/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age47 YR
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