MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-06 for TUBING FOR CPAP manufactured by Ag Industries.
[66823618]
Cpap tubing manufactured by ag industries leaked twice within the past six weeks. This failure constitutes a danger to anyone who has sleep apnea. Replaced tubing after each failure, but am concerned about future failures. Document number: i1710574a. Report number: 20170126-b79e8-2147407649.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5067699 |
| MDR Report Key | 6307502 |
| Date Received | 2017-02-06 |
| Date of Report | 2017-01-26 |
| Date of Event | 2017-01-25 |
| Date Added to Maude | 2017-02-07 |
| 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 | TUBING FOR CPAP |
| Generic Name | TUBING FOR CPAP |
| Product Code | JAY |
| Date Received | 2017-02-06 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AG INDUSTRIES |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-06 |