MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1996-10-18 for ENZOL ENZYMATIC DETERGENT 2252 manufactured by Huntington Laboratories, Inc..
[27459]
Rptr had 2 employees that had exposure to detergent vapors and had acute respiratory distress. One employee went to emergency dept for relief of symptoms. Date of event is approx. Event discovered in conversation with person at user facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1618732-1996-00057 |
| MDR Report Key | 43849 |
| Report Source | 05,06 |
| Date Received | 1996-10-18 |
| Date of Report | 1996-10-17 |
| Date of Event | 1996-07-01 |
| Date Facility Aware | 1996-09-18 |
| Report Date | 1996-10-17 |
| Date Mfgr Received | 1996-09-18 |
| Date Added to Maude | 1996-10-23 |
| 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 | 3 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENZOL ENZYMATIC DETERGENT |
| Generic Name | DETERGENT |
| Product Code | JCB |
| Date Received | 1996-10-18 |
| Model Number | NA |
| Catalog Number | 2252 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 44794 |
| Manufacturer | HUNTINGTON LABORATORIES, INC. |
| Manufacturer Address | 970 E. TIPTON ST HUNTINGTON IN 46750 US |
| Baseline Device Family | ENZYMATIC DETERGENTS |
| Baseline Shelf Life Contained | Y |
| 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 | 1996-10-18 |