MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-07-15 for TRISEPTIN WATERLESS * manufactured by Healthpoint, Ltd..
[18827847]
Triseptin waterless scrub was delivered to the facility. Instead of the correct product, triseptin water-aided scrub. The scrub was dispensed to the operating room surgical scrub sinks by the hospital's sterile processing department. Approx 4 weeks later, a staff member notied the scrub was different and asked the nurse manager about it. The scrub was immediately removed from the or sinks and was replaced with the correct scrub. The antimicrobial effectiveness of both scrubs meets or exceeds fda requirements. Follow-up monitoring of all or patients involved did not show any post-operative infections as a result of the different scrub used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 537590 |
| MDR Report Key | 537590 |
| Date Received | 2004-07-15 |
| Date of Report | 2004-07-06 |
| Date of Event | 2004-04-24 |
| Report Date | 2004-07-06 |
| Date Reported to FDA | 2004-07-06 |
| Date Added to Maude | 2004-08-05 |
| 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 | 3 |
| 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 | TRISEPTIN WATERLESS |
| Generic Name | SURGICAL SCRUB |
| Product Code | GEC |
| Date Received | 2004-07-15 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | 0064-1040-32 |
| Device Expiration Date | 2005-08-01 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 526839 |
| Manufacturer | HEALTHPOINT, LTD. |
| Manufacturer Address | 3909 HULEN ST FORTH WORTH TX 76107 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-07-15 |