MAUDE Adverse Event Report: EZYABSORB KETONE STRIPS; NITROPRUSSIDE, KETONES (URINARY, NON-QUANT)

Device Problems Device Emits Odor (1425); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/22/2020

Event Type  malfunction  

Event Description

Strips are not changing colors, and plastic smell in bottle.Fda safety report id# (b)(4).

• Brand Name: EZYABSORB KETONE STRIPS
• Type of Device: NITROPRUSSIDE, KETONES (URINARY, NON-QUANT)
• MDR Report Key: 9750896
• MDR Text Key: 181331427
• Report Number: MW5093257
• Device Sequence Number: 1
• Product Code: JIN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/20/2020

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: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/24/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 2 DA
• Patient Weight: 101