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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSPIRA SMOOTH COHESIVE SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
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INSPIRA SMOOTH COHESIVE SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED Back to Search Results
Model Number SCL-140
Medical Device Problem Code Material Rupture (1546)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 09/17/2021
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.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: rupture.
 
Event or Problem Description
Patient called to "report a left side rupture and left side "lump", but stated that the doctor believes it is due to "whatever the implant is leaking".Device remains implanted.
 
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Brand Name
INSPIRA SMOOTH COHESIVE SILICONE GEL FILLED BREAST IMPLANT
Common Device Name
PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
MDR Report Key12738211
Report Number9617229-2021-54304
Device Sequence Number1440921
Product Code FTR
UDI-Device Identifier10888628029453
UDI-Public10888628029453
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P020056
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/29/2021
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 Date07/29/2023
Device Model NumberSCL-140
Device Catalogue NumberSCL-140
Device Lot Number3247018
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/04/2021
Initial Report FDA Received Date11/02/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Date Device Manufactured08/29/2018
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age51 YR
Patient Weight53
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