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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES, INC.; PLASTIC SURGERY AND ACCESSORIES KIT
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MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES, INC.; PLASTIC SURGERY AND ACCESSORIES KIT Back to Search Results
Model Number DYNJ82842A
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 03/10/2023
Type of Reportable Event Malfunction
Event or Problem Description
Mid 30¿s female with history of bilateral macromastia.Procedure: bilateral reduction mammoplasty.When the plastic major pack was opened for use, there was a hard, brown debris in the package.Not used on the patient.No known harm.Manufacturer response for plastic surgery and accessories kit, medline industries, inc.(per site reporter) will look into it.
 
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Brand Name
MEDLINE INDUSTRIES, INC.
Common Device Name
PLASTIC SURGERY AND ACCESSORIES KIT
Manufacturer (Section D)
MEDLINE INDUSTRIES, INC.
1170 s northpoint blvd
waukegan IL 60085
MDR Report Key16582028
Report Number16582028
Device Sequence Number11948986
Product Code FTN
UDI-Device Identifier10195327244736
UDI-Public(01)10195327244736(17)20270228(10)22JBJ989
Combination Product (Y/N)N
Initial Reporter StateOH
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type User Facility
Initial Reporter Occupation Risk Manager
Type of Report Initial
Report Date (Section B) 03/13/2023
Report Date (Section F) 03/13/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberDYNJ82842A
Device Catalogue NumberDYNJ82842A
Device Lot Number22JBJ989
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location Hospital
Date Report to Manufacturer03/21/2023
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date03/21/2023
Usage of Device Unknown
Patient Sequence Number1
Patient SexFemale
Patient Weight116 KG
Date Report Sent to FDA03/13/2023
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