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Adverse Event Report

ADVANCED STERILIZATION PRODUCT ENZOL ENZYMATIC DETERGENT   back to search results
Catalog Number 2252
Event Date 07/01/2000
Event Type  Injury   Patient Outcome  Other;
Event Description

Instrument tech using enzol detergent since 1999 purportedly began having a reaction to the product approximately six months ago. Beginning with a rash on the back of the left hand, turning into itchy welts. After diagnosis of latex allergy, the technician switched from using latex gloves to nitrile gloves with no relief. After the welts spread to the technician's feet, chest and back, the technician visited the technician's family physician. The physician thought it might be a reaction or allergy to penicillen prescribed. Lab work was performed to confirm the allergy to latex. The test came back negative. When the technician returned to work, the technician was sent to the er the same day with a rash. The technician's family physician prescribed a prednisone dosepak which gave the technician's immediate relief. The technician's dr prescribed more prednisone along with allegra and tagamet (600 mg) twice per day. When the technician's symptoms returned, the technician was referred to a dermatologist. The dermatologist prescribed ultravate cream with vitamin d3 and discontinued the oral medications. The technician's symptoms worsened over the 2 week course of topical medication. The technician was then referred to an allergist who took skin samples which came back with a negative result. The allergist felt that the penicillin could have caused hypersensitivity when using the enzol detergent. The allergist prescribed zyrtec, which seemed to work but made the technician drowsy. The technician then prescribed singulair which has appeared to help the symptoms somewhat. The technician is now taking singulair, allegra and tagamet twice per day. They have changed to endozyme aw+ unscented.

 
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Brand NameENZOL ENZYMATIC DETERGENT
Type of DeviceENZYMATIC DETERGENT
Baseline Brand NameENZOL ENZYMATIC DETERGENT
Baseline Generic NameENZYMATIC DETERGENT
Baseline Catalogue Number2252
Baseline Model Number2252
Baseline Device FamilyDETERGENT
Baseline Device 510(K) Number
Baseline Device PMA Number
Baseline Shelf Life Information
Baseline Preamendment? No
Transitional? No
510(K) Exempt? Yes
Shelf Life(Months)24
Date First Marketed09/09/1991
Manufacturer (Section F)
ADVANCED STERILIZATION PRODUCT
33 technology dr
irvine CA 92618
Manufacturer (Section D)
ADVANCED STERILIZATION PRODUCT
33 technology dr
irvine CA 92618
Manufacturer Contact
kathleen roberts
33 technology drive
irvine , CA 92618
(949) 453 -6411
Device Event Key305939
MDR Report Key316386
Event Key297430
Report Number2084725-2001-00011
Device Sequence Number1
Product CodeJCB
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 02/16/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/16/2001
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Other
Device EXPIRATION Date10/01/2002
Device Catalogue Number2252
Device LOT NumberL100201
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/19/2001
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/01/2000
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

Database last updated on January 30, 2009

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