MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2015-12-15 for HUDSON NEBULIZER W/ADULT MASK & TBG, SMALL VOL 41893 manufactured by Teleflex Medical.
[33497891]
(b)(4). A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned for evaluation. A device history record review could not be conducted since the lot number was not provided. No corrective action can be established at this time since the device sample, picture or batch number are not available for evaluation. The device sample is necessary to conduct a proper investigation. Customer complaint cannot be confirmed due to the lack of device sample to perform a proper investigation and determine the root cause. If the device sample becomes available this compliant will be reopened.
Patient Sequence No: 1, Text Type: N, H10
[33497894]
The customer alleges that the solution within the nebulizer chamber does not aerolize or steam.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2015-00387 |
| MDR Report Key | 5297550 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2015-12-15 |
| Date of Report | 2015-12-01 |
| Date of Event | 2015-11-27 |
| Date Mfgr Received | 2015-12-01 |
| Date Added to Maude | 2015-12-15 |
| 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 | MARGIE BURTON, RN |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334965 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | PARQUE INDUSTRIAL FINSA |
| Manufacturer City | NUEVO LAREDO 88275 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88275 |
| 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 | ADULT SMALL VOL. NEBULIZER |
| Product Code | CCQ |
| Date Received | 2015-12-15 |
| Catalog Number | 41893 |
| Lot Number | UNKNOWN |
| Device Availability | N |
| 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 | 2015-12-15 |