MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-19 for CPAP 6' TUBING EASY-FLEX6 manufactured by Roscoe Medical/compass Health Brands.
[137257533]
I used plastic tubing from a company roscoe for my cpap machine. The tubing attaches to the machine, which attaches to my mask and i breathe through it throughout the night. After breathing through the new roscoe tube, i awoke unable to breathe, sore throat, closed up throat, sinus distress, heavy chest. I changed back to my original tubing the next night and had no trouble, started to improve. Product description: connector on both ends. Dark gray. Retailer: (b)(6). Purchase date: (b)(6) 2018. Document number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084159 |
| MDR Report Key | 8358820 |
| Date Received | 2019-02-19 |
| Date of Report | 2019-02-19 |
| Date of Event | 2018-12-29 |
| Date Added to Maude | 2019-02-21 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | 0 |
| Brand Name | CPAP 6' TUBING |
| Generic Name | TUBING, PRESSURE AND ACCESSORIES |
| Product Code | BYX |
| Date Received | 2019-02-19 |
| Model Number | EASY-FLEX6 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROSCOE MEDICAL/COMPASS HEALTH BRANDS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-19 |