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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORASURE TECHNOLOGIES, INC. SCHOLL FREEZE VERRUCA & WART REMOVER FREEZE `N CLEAR SKIN CLINIC ADVANCED WART REMOVER

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ORASURE TECHNOLOGIES, INC. SCHOLL FREEZE VERRUCA & WART REMOVER FREEZE `N CLEAR SKIN CLINIC ADVANCED WART REMOVER Back to Search Results
Lot Number 7276
Event Date 12/11/2009
Event Type  Malfunction  
Event Description

Initial info: i placed the can on my kitchen surface and pressed the cap firmly down whilst counting for 5 secs, i got to 3 and the bud set on fire, i took it out and put it in the sink whilst doing this, i singed the hair on my fingers. F/u questioning revealed the following. The canister was stored in the bathroom medicine cabinet. The temperature in the bathroom is what the consumer would consider normal, she said they used the shower in the mornings and that would mean it could be a damp atmosphere then, but otherwise a normal temp. She had read and understood the directions as she had used it a couple of times before, she was retreating. Nothing unusual (noticeable product defects) were observed. It was being used in the kitchen as there was plenty of flat surfaces to use the spray correctly, she used it early evening after she put her children to bed so that she wouldn't be disturbed whilst using it. The temp was what she would class as normal house temp, no drafts or humidity. She has a gas cooker in the kitchen but this was not on and no other appliances were on, she was not anywhere near the cooker. (no other ignition source identified. ).

 
Manufacturer Narrative

The implicated product was not returned to orasure technologies at the time of this report. If the product is received, it will be evaluated and the file will be updated appropriately. A lot history search revealed no reports of "fire caused" for lot 7276 revealed no similar reports. A review of reported incidents across all related product lines also did not reveal any similar reported incidents. No abnormalities were noted during lot release testing. The product outer carton of the us product is labeled as, "extremely flammable. Contents under pressure. Keep away from fire or flame. Do not smoke while using this product. Do not expose to heat or store at temperatures above 120f. Store at room temp away from heat. " the current us canister contains the following warning, "extremely flammable. Keep away from fire or flame. Do not smoke while using this product. Do not expose to heat or store at temps above 120f. Store at room temp away from heat. " the consumer indicated it was not used near the stove but did not indicate if any other ignition source was present at the time of use when directly asked. Review of the msds and risk analysis did not reveal any other possible reason for the flame to occur except exposure to an ignition source. This complaint will be resolved as unk at this time.

 
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Brand NameSCHOLL FREEZE VERRUCA & WART REMOVER
Type of DeviceFREEZE `N CLEAR SKIN CLINIC ADVANCED WART REMOVER
Manufacturer (Section F)
ORASURE TECHNOLOGIES, INC.
bethlehem PA
Manufacturer (Section D)
ORASURE TECHNOLOGIES, INC.
bethlehem PA
Manufacturer Contact
jackie ferro, dir
220 east first st
bethlehem , PA 18015
(610) 882 -1820
Device Event Key1737058
MDR Report Key1626433
Event Key1547055
Report Number2528909-2010-00001
Device Sequence Number1
Product CodeGEH
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 01/13/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/15/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Lay User/Patient
Device EXPIRATION Date10/31/2010
Device LOT Number7276
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was The Report Sent To Manufacturer? No
Date Manufacturer Received01/13/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/01/2007
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 02/15/2010 Patient Sequence Number: 1
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