MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-03-17 for SHORT TERM SWAB SYSTEM * 6000 manufactured by Sage Products, Llc.
[5609637]
When opening a sealed carton of the sage # 6000 mouth care kits, we noticed it was infested with dead insects. It appeared none were in the packages itself, just in the shipping container. We feel the lot number could be either 47020 or 47301.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4656695 |
| MDR Report Key | 4656695 |
| Date Received | 2015-03-17 |
| Date of Report | 2015-03-17 |
| Date of Event | 2015-02-13 |
| Report Date | 2015-03-17 |
| Date Reported to FDA | 2015-03-17 |
| Date Reported to Mfgr | 2015-04-03 |
| Date Added to Maude | 2015-04-03 |
| 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 |
| 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 | SHORT TERM SWAB SYSTEM |
| Generic Name | PATIENT PERSONAL HYGIENE KIT |
| Product Code | NSB |
| Date Received | 2015-03-17 |
| Model Number | * |
| Catalog Number | 6000 |
| Lot Number | 47301 OR 47020 |
| ID Number | * |
| Device Age | 1 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SAGE PRODUCTS, LLC |
| Manufacturer Address | 3909 3 OAKS RD. CARY IL 60013 US 60013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-17 |