BACK SUPPORT BELT HC109

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-03-22 for BACK SUPPORT BELT HC109 manufactured by Tectron.

Event Text Entries

[3317625] Purchased back support belt from consumer shopping through (b)(6). Opened the package of the first back support belt, an odor emitted from it and a water substance was leaking from it. Contacted the seller and they agreed to send him another one. Pt received the second back support belt on (b)(6) 2013 and a noticeable odor emitted from it as well. The toxic fume filled the room which made pt nauseous. There is a label warning on the device indicating it can cause cancer, birth defects and reproductive harm. Pt is concerned that the device is toxic which can cause serious problems to consumers.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	MW5029430
MDR Report Key	3020651
Date Received	2013-03-22
Date of Report	2013-03-22
Date of Event	2013-03-11
Date Added to Maude	2013-03-27
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	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 Sequence Number: 1

Brand Name	BACK SUPPORT BELT
Generic Name	BACK SUPPORT BELT
Product Code	IQE
Date Received	2013-03-22
Catalog Number	HC109
Operator	LAY USER/PATIENT
Device Availability	Y
Device Sequence No	1
Device Event Key	0
Manufacturer	TECTRON

Device Sequence Number: 2

Brand Name	BACK SUPPORT BELT
Generic Name	BACK SUPPORT BELT
Product Code	IQE
Date Received	2013-03-22
Catalog Number	HC109
Operator	LAY USER/PATIENT
Device Availability	Y
Device Sequence No	2
Device Event Key	0
Manufacturer	TECTRON

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2013-03-22