MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-11-12 for SHUR-CLENS * manufactured by Calgon Vestal Lab..
[17112029]
Respiratory therapist lavaged pt's tracheostomy tube with 20cc ampule of solution therapist thought was using saline, but it was a soap solution. Physician was informed and pt lavaged and suctioned numerous times immediately afterward to clear airway. Only about 5cc of solution had been used. The soap solution, is in a clear vial marked "not for injection", but is not identified as a soap solution.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 50463 |
| MDR Report Key | 50463 |
| Date Received | 1996-11-12 |
| Date of Report | 1996-10-03 |
| Date of Event | 1996-08-24 |
| Date Facility Aware | 1996-09-06 |
| Report Date | 1996-10-03 |
| Date Reported to Mfgr | 1996-10-03 |
| Date Added to Maude | 1996-11-22 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHUR-CLENS |
| Generic Name | AMPULE OF SOAP SOLUTION |
| Product Code | MDZ |
| Date Received | 1996-11-12 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 51168 |
| Manufacturer | CALGON VESTAL LAB. |
| Manufacturer Address | PO BOX 147 7501 PAGE AVE ST LOUIS MO 631660147 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-11-12 |