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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 168 SALINE FILLED BREAST IMPLANT; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
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ALLERGAN (COSTA RICA) STYLE 168 SALINE FILLED BREAST IMPLANT; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE Back to Search Results
Model Number 168-480
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 08/06/2020
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 noted, a supplemental medwatch will be submitted.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
Healthcare professional reported left side deflation and "patients concern with the product".Device has been explanted.
 
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Brand Name
STYLE 168 SALINE FILLED BREAST IMPLANT
Common Device Name
PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
Manufacturer (Section D)
ALLERGAN (COSTA RICA)
900 parkway global park
zona franca
CS 
MDR Report Key10465399
Report Number9617229-2020-13982
Device Sequence Number11557693
Product Code FWM
UDI-Device Identifier10888628000872
UDI-Public10888628000872
Combination Product (Y/N)N
Initial Reporter StateCA
PMA/510(K) Number
P990074
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2020
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/28/2020
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 Date01/18/2019
Device Model Number168-480
Device Catalogue Number168-480
Device Lot Number2708544
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/06/2020
Initial Report FDA Received Date08/28/2020
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;
Patient Age46 YR
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