MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-09-06 for CABLES TOGO 48000 manufactured by Cables Togo.
[2881904]
Product purchased through gsa (cables togo). With no ul approval on hospital grade power cords. Power cords were listed as made in the usa. The power cords were sold and resold (b)(4), before receiving them from (b)(4). I have also found many oem replacement power cords do not meet the standard. Bottom line when equipment, is remanufactured overseas, the same safety requirements are not followed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5026808 |
| MDR Report Key | 2732746 |
| Date Received | 2012-09-06 |
| Date of Report | 2011-12-15 |
| Date of Event | 2011-12-15 |
| Date Added to Maude | 2012-09-10 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CABLES TOGO |
| Generic Name | 16 AWG HOSPITAL GRADE POWER CORDS |
| Product Code | LDQ |
| Date Received | 2012-09-06 |
| Model Number | 48000 |
| Lot Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CABLES TOGO |
| Manufacturer Address | 3555 KETTERING BLVD MORAINE OH 45439 US 45439 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-09-06 |