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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 20 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
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ALLERGAN (COSTA RICA) STYLE 20 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED Back to Search Results
Catalog Number 20-280
Medical Device Problem Code Material Rupture (1546)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 11/15/2019
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.Reason for reoperation: rupture.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.
 
Event or Problem Description
Healthcare professional reported right side rupture.Device has been explanted.
 
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Brand Name
STYLE 20 SILICONE GEL FILLED BREAST IMPLANT
Common Device Name
PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
Manufacturer (Section D)
ALLERGAN (COSTA RICA)
900 parkway global park
zona franca
CS 
MDR Report Key9497561
Report Number9617229-2019-20856
Device Sequence Number16664074
Product Code FTR
UDI-Device Identifier10888628001657
UDI-Public10888628001657
Combination Product (Y/N)N
Initial Reporter StateUT
PMA/510(K) Number
P020056
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2019
Reporter Type Manufacturer
Report Source consumer,health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/19/2019
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 Date11/16/2019
Device Catalogue Number20-280
Device Lot Number2685226
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/22/2019
Initial Report FDA Received Date12/19/2019
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 Age49 YR
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