MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES, INC.; PLASTIC SURGERY AND ACCESSORIES KIT

Model Number DYNJ82842A

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/10/2023

Event Type  malfunction  

Event 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.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Type of Device: PLASTIC SURGERY AND ACCESSORIES KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; 1170 s northpoint blvd; waukegan IL 60085
• MDR Report Key: 16582028
• MDR Text Key: 311670946
• Report Number: 16582028
• Device Sequence Number: 1
• Product Code: FTN
• UDI-Device Identifier: 10195327244736
• UDI-Public: (01)10195327244736(17)20270228(10)22JBJ989
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: DYNJ82842A
• Device Catalogue Number: DYNJ82842A
• Device Lot Number: 22JBJ989
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/13/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/21/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/21/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 13140 DA
• Patient Sex: Female
• Patient Weight: 116 KG