MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-16 for HUDSON NEBULIZER W/ADULT MASK & TBG, SMALL VOL 41893 manufactured by Teleflex Medical.
[38865998]
(b)(4). The results of the investigation are incomplete at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
[38865999]
The customer alleges that the nebulizer did not function with an oxygen flow that's superior to 16l/mn.
Patient Sequence No: 1, Text Type: D, B5
[43021270]
(b)(4). Corrected data: procode has been corrected to caf. A device history record (dhr) was performed and there were no issues found that could relate to the reported complaint. The device was not returned for evaluation; therefore, the complaint could not be confirmed. If the device is returned, a follow-up report will be submitted with investigation results.
Patient Sequence No: 1, Text Type: N, H10
[43021271]
The customer alleges that the nebulizer did not function with an oxygen flow that's superior to 16l/mn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011137372-2016-00032 |
| MDR Report Key | 5439048 |
| Date Received | 2016-02-16 |
| Date of Report | 2016-02-09 |
| Date of Event | 2016-02-01 |
| Date Mfgr Received | 2016-03-21 |
| Date Added to Maude | 2016-02-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | KATHARINE TARPLEY |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334854 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27560 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON NEBULIZER W/ADULT MASK & TBG, SMALL VOL |
| Generic Name | NEBULIZER, NON-VENTILATORY |
| Product Code | CCQ |
| Date Received | 2016-02-16 |
| Catalog Number | 41893 |
| Lot Number | 151004 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-16 |