MOUTH SWAB

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-02-03 for MOUTH SWAB manufactured by .

Event Text Entries

[4089471] I had my first mouth swab drug test, all others were urine. I was prescribed morphine sulfate. The results were that i was on heroin and no morphine showed at all. I know this is wrong because i have never used it in my entire life and i'm (b)(6) years old. They did not believe me and treated me dreadful. The test was done on (b)(6) and processed at the lab (b)(6). I live in (b)(6). But the lab that processes is in (b)(6). Advanced pain management.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5034200
• MDR Report Key: 3610556
• Date Received: 2014-02-03
• Date of Report: 2014-01-31
• Date of Event: 2013-10-07
• Date Added to Maude: 2014-02-07
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: PATIENT
• Health Professional: 0
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: MOUTH SWAB
• Generic Name: MOUTH SWAB
• Product Code: MGX
• Date Received: 2014-02-03
• ID Number: 2 PARTS, ONE IN EACH CHEEK
• Device Expiration Date: 2013-10-07
• Operator: HEALTH PROFESSIONAL
• Device Sequence No: 1
• Device Event Key: 0

Device Sequence Number: 2

• Brand Name: MOUTH SWAB
• Generic Name: MOUTH SWAB
• Product Code: MGX
• Date Received: 2014-02-03
• Device Sequence No: 2
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2014-02-03