DR. SCHOLL'S AIR-PILLOW ULTRA INSOLES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-11-07 for DR. SCHOLL'S AIR-PILLOW ULTRA INSOLES manufactured by .

Event Text Entries

[2567933] A u. S. Serious spontaneous report was received from a female consumer, age and race not provided, initials anonymized. Medical history and concomitant medications not provided. Consumer reported that she used a dr. Scholls (no active ingredients) "white foam foot pads" in 2008. No specific product was identified. The consumer reported "in 2008 had a allergic reaction to your white foam pads. " she stated "was give meds to heal the reaction, then a snow ball effect of adverse reactions, causing me to be bed ridden. " she stated "3 later, i am in great pain and walking is difficult. " she stated "many doctors visits later, i am told i am allergic to something touching my feet. " she stated that because she had the initial reaction from the foam pads, she is now allergic to whatever the ingredients are in the white foam pads. No specific product was identified. (b)(6) 2011 update phone: the consumer reported "i am calling to let you know that i am filling the questionnaire that you sent me. I want you to know that i am not blaming your company. I have been bandaged up for 2 years. I have had staff infections and the doctor is the cause of my problems. I used your foam insoles. Air pillows that is the name. I am now being seen and tested and for what i am allergic to with a patch test. Can you tell me the ingredients of the air pillow product? I threw away the insoles. I have to wear bedroom slippers all the time. My feet are always swollen. I am (b)(6). I was bedridden for awhile. The doctor gave me some anti-fungal medication to use on my feet and he burned them. These doctors can hurt you worse. "
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1031623-2011-46709
MDR Report Key2419247
Report Source04
Date Received2011-11-07
Date of Report2011-10-28
Date Mfgr Received2011-10-10
Date Added to Maude2012-01-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA0
Event Location0
Manufacturer Street50 LAWRENCE RD
Manufacturer CitySPRINGFIELD NJ 07081
Manufacturer CountryUS
Manufacturer Postal07081
Manufacturer Phone9739217435
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameDR. SCHOLL'S AIR-PILLOW ULTRA INSOLES
Generic NameNONE
Product CodeKYS
Date Received2011-11-07
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2011-11-07

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