ACTIV FLEX BANDAGES *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-03-05 for ACTIV FLEX BANDAGES * manufactured by Johnson And Johnson.

Event Text Entries

[18494628] Activ flex bandages from bandaid do not properly educate the consumer: the entire active flex bandage sticks to the skin and seals the wound, allowing internal moisture to improve healing. The bandage is meant to be left on for a few days while a white fluid forms from absorption. This is a good product, but: 1. The package does not say anything about leaving the bandage on for any extended period. 2. No instruction says how many days that it should be kept on. 3. No instruction says at what point it has been on too long. 4. The only warnings say to not put it on stitches or burns. Nothing about any other type of wounds. Nothing about potential problems using the bandage. A new user is inclined to use old habits, so after the activ flex is on for 8-10 hours, a very long time for most bandages, he may decide to remove it. The problem is that the superior adhesive of activ flex will rip the wound apart during removal, causing more damage. Once educated of this multi-day feature, there is no indication for the consumer on when it is time to remove the bandage. Since it stays on so well, there seems to be no reason to take it off. On the fourth day of my application, i removed my bandage to find a pervasive brown goo, the smell of rotten flesh, and significant pulling away and detachment of the skin from healthy areas under the bandage (which had turned white from all the moisture). I am not sure if this is what doctors would want to see under a dressing. I have not been able to see the clinical trials on this product, and i am very interested in how it was tested.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1042111
MDR Report Key824655
Date Received2007-03-05
Date of Report2007-03-05
Date of Event2007-03-01
Date Added to Maude2007-03-12
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameACTIV FLEX BANDAGES
Generic NameBANDAID
Product CodeKAX
Date Received2007-03-05
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Age*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key812055
ManufacturerJOHNSON AND JOHNSON
Manufacturer Address* * *


Patients

Patient NumberTreatmentOutcomeDate
10 2007-03-05

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