MAUDE Adverse Event Report: PRODUCTS, INC. 37000N HAIR TEST; ENZYME IMMUNOASSAY, AMPHETAMINE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/26/2022

Event Type  malfunction  

Event Description

My hair test came back positive for methamphetamine when taking wellbutrin.Fda safety report id# (b)(4).

• Brand Name: 37000N HAIR TEST
• Type of Device: ENZYME IMMUNOASSAY, AMPHETAMINE
• Manufacturer (Section D): PRODUCTS, INC.
• MDR Report Key: 15720376
• MDR Text Key: 303058820
• Report Number: MW5113051
• Device Sequence Number: 1
• Product Code: DKZ
• 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: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Treatment: SUDATED; VYVANSE; WELLBUTRIN
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White