CVS ULTRA-SOFT SILICONE EARPLUGS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-12-12 for CVS ULTRA-SOFT SILICONE EARPLUGS manufactured by Cvs/pharmacy, Inc..

Event Text Entries

[20618822] I believe there is a manufacturing contamination of cvs's silicone ear plugs. I have used this product in the past without problem. I rolled out an ear plug and put it around the edge of my cpap mask. After i put on my mask, within a very short period of time, my face was burning where the mask was touching. I thought perhaps i was becoming allergic to the silicone, so i switched to a different mask that night. A closer examination of the silicone on the mask revealed the presence of small white sharp splinters of some kind. I can only assume they are somehow related to the burning, as i have since used a different brand of silicone without irritation. Fortunately, i did not leave it on my face along enough to cause a problem with my skin, -i hope-. Unfortunately, when i took the silicone off of my mask, it appears to have damaged the mask. I guess there is some chemical contamination of the ear plugs, in addition to the splinters. I stopped by the pharmacy on the way home from work a few days ago. They say that no problem with this product has been reported. This surprised me somewhat, because i cannot imagine that these plugs could be used in your ears or anywhere else without extreme irritation. Dates of use: 2008. Diagnosis or reason for use: improve seal on cpap mask. Event abated after use stopped or dose reduced: yes.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5009357
MDR Report Key1274204
Date Received2008-12-12
Date of Report2008-12-12
Date of Event2008-12-08
Date Added to Maude2009-01-21
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameCVS ULTRA-SOFT SILICONE EARPLUGS
Generic NameSILICONE EARPLUGS
Product CodeEWD
Date Received2008-12-12
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerCVS/PHARMACY, INC.
Manufacturer AddressWOONSOCKET RI 02895 US 02895


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2008-12-12

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