MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2001-02-16 for ENZOL ENZYMATIC DETERGENT 2252 manufactured by Advanced Sterilization Product.
[22176403]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2084725-2001-00011 |
| MDR Report Key | 316386 |
| Report Source | 05,06 |
| Date Received | 2001-02-16 |
| Date of Report | 2001-02-16 |
| Date of Event | 2000-07-01 |
| Date Mfgr Received | 2001-01-19 |
| Device Manufacturer Date | 2000-10-01 |
| Date Added to Maude | 2001-02-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | KATHLEEN ROBERTS |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9494536411 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENZOL ENZYMATIC DETERGENT |
| Generic Name | ENZYMATIC DETERGENT |
| Product Code | JCB |
| Date Received | 2001-02-16 |
| Model Number | NA |
| Catalog Number | 2252 |
| Lot Number | L100201 |
| ID Number | NA |
| Device Expiration Date | 2002-10-01 |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 305939 |
| Manufacturer | ADVANCED STERILIZATION PRODUCT |
| Manufacturer Address | 33 TECHNOLOGY DR IRVINE CA 92618 US |
| Baseline Brand Name | ENZOL ENZYMATIC DETERGENT |
| Baseline Generic Name | ENZYMATIC DETERGENT |
| Baseline Model No | 2252 |
| Baseline Catalog No | 2252 |
| Baseline ID | NA |
| Baseline Device Family | DETERGENT |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-02-16 |