MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-29 for DRIVE TUB NK 25 manufactured by Unknown.
[109402470]
(b)(4) is the initial importer of the device which is a respiratory accessory of 25 foot tubing. (b)(4) was notified by this event through a medwatch report number 101545-2018-00007 which codes device issue as : problem associated with the use of the device in terms of nonconforming to that device's intended use, specifications, procedure and process or service instructions and information provided by the device manufacturers and an adverse event (e. G. Patient harm) appears to have occurred, but there does not appear to have been a problem with the device or the way it was used. Patient exited the car unassisted with oxygen tubing wrapped around his legs and sustained a fracture of the right hip due to his fall to the ground. Patient was taken to the hospital where he remained until death two days after the fall.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2018-00029 |
| MDR Report Key | 7548604 |
| Date Received | 2018-05-29 |
| Date of Report | 2018-05-29 |
| Date of Event | 2018-05-01 |
| Date Facility Aware | 2018-05-22 |
| Report Date | 2018-05-29 |
| Date Reported to FDA | 2018-05-29 |
| Date Added to Maude | 2018-05-29 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| 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 | DRIVE |
| Generic Name | TUBING |
| Product Code | BYX |
| Date Received | 2018-05-29 |
| Model Number | TUB NK 25 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Hospitalization | 2018-05-29 |