MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-01-17 for COMFORT PERSONAL CLEANSING * 7856 manufactured by Sage Products.
[4136991]
The sage comfort essential bath wipes leak. The bag opens when in the warmers and the soap drains onto the warming units.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3588735 |
| MDR Report Key | 3588735 |
| Date Received | 2014-01-17 |
| Date of Report | 2014-01-17 |
| Date of Event | 2014-01-13 |
| Report Date | 2014-01-17 |
| Date Reported to FDA | 2014-01-17 |
| Date Reported to Mfgr | 2014-01-23 |
| Date Added to Maude | 2014-01-23 |
| 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 |
| 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 | COMFORT PERSONAL CLEANSING |
| Generic Name | PATIENT PERSONAL HYGIENE KIT, BATH WIPES |
| Product Code | NSB |
| Date Received | 2014-01-17 |
| Model Number | * |
| Catalog Number | 7856 |
| Lot Number | 41094/1A |
| ID Number | * |
| Device Availability | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SAGE PRODUCTS |
| Manufacturer Address | 3909 THREE OAKS ROAD CARY IL 60013 US 60013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-01-17 |