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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HANSON MEDICAL INC HANSON MEDICAL MALAR IMPLANT
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HANSON MEDICAL INC HANSON MEDICAL MALAR IMPLANT Back to Search Results
Model Number M 4 - 3
Health Effect - Clinical Code Discomfort (2330)
Date of Event 05/24/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Method: reviewed the complaint notes, device history record, risk analysis, and product labeling.Results: review of the complaint notes and device history record revealed no assignable cause for the reported event.Extrusion is a known risk.Product labeling cautions: "complications, although uncommon, include infection, extrusion, implant movement, pain, itching, irritation, fluid accumulation, bleeding, bruising, and capsular contracture.".
 
Event or Problem Description
Physician reported that a patient presented with extrusion of the left malar implant on (b)(6) 2019.Originally implanted on (b)(6) 2019 after which the patient felt discomfort.Subsequently, implants were removed bilateral on (b)(6) 2019.
 
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Brand Name
HANSON MEDICAL MALAR IMPLANT
Common Device Name
MALAR IMPLANT
Manufacturer (Section D)
HANSON MEDICAL INC
825 riverside ave. suite 2
paso robles CA 93446
MDR Report Key8745468
Report Number2031444-2019-00001
Device Sequence Number13963083
Product Code LZK
UDI-Device IdentifierB049M430
UDI-Public+B049M430/$$715943Q
Combination Product (Y/N)N
Initial Reporter CountryCO
PMA/510(K) Number
K973574
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/28/2019
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 Model NumberM 4 - 3
Device Catalogue NumberM 4 - 3
Device Lot Number15943
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/04/2019
Initial Report FDA Received Date06/28/2019
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 Hospitalization;
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