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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE TE SMOOTH 133S-MV-16-T; EXPANDER, SKIN, INFLATABLE
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ALLERGAN (COSTA RICA) NATRELLE TE SMOOTH 133S-MV-16-T; EXPANDER, SKIN, INFLATABLE Back to Search Results
Model Number 133S-MV-16-T
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code Failure of Implant (1924)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
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: "folded over on itself" and "deflation".
 
Event or Problem Description
Healthcare professional reported unknown side "folded over on itself" and "deflation." device remains implanted.
 
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Brand Name
NATRELLE TE SMOOTH 133S-MV-16-T
Common Device Name
EXPANDER, SKIN, INFLATABLE
Manufacturer (Section D)
ALLERGAN (COSTA RICA)
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MDR Report Key12221037
Report Number9617229-2021-47738
Device Sequence Number19202487
Product Code LCJ
UDI-Device Identifier10888628043909
UDI-Public10888628043909
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
K182054
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/23/2021
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 Model Number133S-MV-16-T
Device Catalogue Number133S-MV-16-T
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/25/2021
Initial Report FDA Received Date07/23/2021
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;
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