MAUDE Adverse Event Report: MERIT MEDICAL, SYSTEMS, INC. MERIT DRAINAGE DEPOT MDD600; BAG, BILE COLLECTING

Model Number	MDD600 VERSION A
Health Effect - Clinical Codes	Nausea (1970); No Code Available (3191)
Date of Event	10/16/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Nausea and loss of appetite due to persistent foul odor.Fda safety report id# (b)(4).

• Brand Name: MERIT DRAINAGE DEPOT MDD600
• Common Device Name: BAG, BILE COLLECTING
• Manufacturer (Section D): MERIT MEDICAL, SYSTEMS, INC.
• MDR Report Key: 9525211
• Report Number: MW5091904
• Device Sequence Number: 19418411
• Product Code: EXF
• UDI-Device Identifier: 00884450008256
• UDI-Public: (01)00884450008256(17)22083(10)
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 12/25/2019

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/31/2022
• Device Model Number: MDD600 VERSION A
• Device Lot Number: I1644721
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/26/2019
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 112