STOMAHESIVE 183910

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-09-23 for STOMAHESIVE 183910 manufactured by Convatec, Inc..

Event Text Entries

[2281730] I was given a paste to use on my diabetic type ulcer to make a good seal with a wound vac. This paste is usually used for colostomy bags. After a few hours, i started to feel strange, uneasy, paranoid w/anxiety and started to have mild hallucinations an delusions. Thank god i was in the doctor's office when all of this began. When i mentioned the wound care ladies experiment with the paste then the doctor figured out what happened and how to proceed from that point. The event lasted three days and ended with no problems. Frequency: once per day on wound.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	MW5022516
MDR Report Key	2281640
Date Received	2011-09-23
Date of Report	2011-09-19
Date of Event	2011-09-07
Date Added to Maude	2011-10-11
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	3
Event Location	0
Single Use	0
Previous Use Code	0
Event Type	3
Type of Report	3

Device Sequence Number: 1

Brand Name	STOMAHESIVE
Generic Name	COLOSTOMY PASTE
Product Code	EZS
Date Received	2011-09-23
Catalog Number	183910
Lot Number	1212956C4
Operator	HEALTH PROFESSIONAL
Device Availability	Y
Device Sequence No	1
Device Event Key	0
Manufacturer	CONVATEC, INC.
Manufacturer Address	SKILMAN NC 08558 US 08558

Device Sequence Number: 2

Brand Name	KCI
Generic Name	WOUND VAC
Product Code	OMP
Date Received	2011-09-23
Operator	HEALTH PROFESSIONAL
Device Sequence No	2
Device Event Key	0
Manufacturer	KCI

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening; 2. Other; 3. Required No Informationntervention	2011-09-23