MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,06,07 report with the FDA on 1998-04-21 for ENZOL ENZYMATIC DETERGENT 2252 manufactured by Advanced Sterilization Product.
[21379464]
Initial caller informed advanced sterilization product that a health care professional at a gyn office used enzol while soaking and cleaning speculums. The health care professional experienced tongue swelling, shortness of breath, headaces and dizziness which she attributes to working with enzol enviroment, and a follow up phone conversation indicates no further issues. The initial reporter states that "now they are not sure that the particular employee is allergic to enzol".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2084725-1998-00015 |
| MDR Report Key | 164070 |
| Report Source | 04,05,06,07 |
| Date Received | 1998-04-21 |
| Date of Report | 1998-04-20 |
| Date of Event | 1998-03-30 |
| Date Mfgr Received | 1998-03-30 |
| Device Manufacturer Date | 1998-01-01 |
| Date Added to Maude | 1998-04-27 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENZOL ENZYMATIC DETERGENT |
| Generic Name | DETERGENT |
| Product Code | JCB |
| Date Received | 1998-04-21 |
| Model Number | NA |
| Catalog Number | 2252 |
| Lot Number | LO11381 |
| ID Number | NA |
| Device Expiration Date | 2000-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 159708 |
| 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. Required No Informationntervention | 1998-04-21 |