MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,06 report with the FDA on 1998-03-16 for ENZOL ENZYMATIC DETERGENT 2252 manufactured by Ecolab Inc..
[106197]
The customer called in with a report of an employee opthalmic contact with enzol enzymatic detergent. She irrigated her eyes and rec'd medical attention. A f/u phone call indicated that she had been examined by a physician who reported normal findings after examining the eyes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2084725-1998-00008 |
| MDR Report Key | 157673 |
| Report Source | 04,05,06 |
| Date Received | 1998-03-16 |
| Date of Report | 1998-03-16 |
| Date of Event | 1998-03-05 |
| Date Mfgr Received | 1998-03-05 |
| Date Added to Maude | 1998-03-20 |
| 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 | 1998-03-16 |
| Model Number | NA |
| Catalog Number | 2252 |
| Lot Number | UNK |
| ID Number | NA |
| 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 | 153621 |
| Manufacturer | ECOLAB INC. |
| Manufacturer Address | 970 EAST TIPTON ST HUNTINGTON IN 46750 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 | 1998-03-16 |