UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-07-10 for UNK manufactured by Cellestis Inc.

Event Text Entries

[19924501] Approx 3 weeks ago at (b)(6), i was skin tested for (b)(6) and it came out (b)(6) following that a few days later, i had a blood test taken and after 3 weeks, it came out (b)(6). At the same time, i was scheduled to take an annual physical at the va hospital in (b)(6) and that test was sent to (b)(6) and came back (b)(6). The blood samples from (b)(6) that draw my blood used the regular tubes and did not use the mitogen control tubes to draw my blood but the laboratory technician at the va in (b)(6) did use the special tubes to draw my blood. Because of the impact of loosing a tentative job and also my health risk and others, request assistance in investigating the two mfg's of the test control, and the laboratory results, procedures and qualifications. Dates of use: (b)(6) 2013 - (b)(6) 2013. Diagnosis or reason for use: verify (b)(6) skin test. The (b)(6) drew the blood and sent it to (b)(6).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	MW5031071
MDR Report Key	3252329
Date Received	2013-07-10
Date of Report	2013-07-10
Date of Event	2013-07-02
Date Added to Maude	2013-07-30
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
Health Professional	3
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 Details

Brand Name	UNK
Generic Name	QUANTIFORM TB GOLD
Product Code	NCD
Date Received	2013-07-10
Device Availability	N
Device Sequence No	1
Device Event Key	0
Manufacturer	CELLESTIS INC
Manufacturer Address	VALENCIA CA US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening; 2. Other	2013-07-10