MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-29 for ROSCOE MEDICAL EASY-FLEX6 manufactured by Worldcross Industries Co., Ltd.
[140339302]
The consumer used the tubing for her cpap machine. After breathing through the new tubing all night, she awoke unable to breathe with a sore throat, closed up throat, sinus distress and a heavy chest. She changed back to her original tubing and had no trouble. She started to improve. She said that it was new in the package and that there was powder in the tubing. She states that she purchased the tubing in 2018. She said that she took the tubing to her doctor and her doctor said that it was the cause of her problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012316249-2019-00011 |
| MDR Report Key | 8465584 |
| Date Received | 2019-03-29 |
| Date of Report | 2019-03-29 |
| Date of Event | 2018-12-29 |
| Date Facility Aware | 2019-03-12 |
| Report Date | 2019-03-29 |
| Date Reported to FDA | 2019-03-29 |
| Date Reported to Mfgr | 2019-03-29 |
| Date Added to Maude | 2019-03-29 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROSCOE MEDICAL |
| Generic Name | EASY-FLEX 6' CPAP TUBING |
| Product Code | BZO |
| Date Received | 2019-03-29 |
| Model Number | EASY-FLEX6 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WORLDCROSS INDUSTRIES CO., LTD |
| Manufacturer Address | NO. 8 YUANSHAN ROAD HEGDIAN ELECTRONIC INDUSTRY PA DONG YANG ZHEJIANG, CHINA, 322118 CH 322118 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-29 |