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 2017-02-23 for HUDSON MASK,NON-REBREATH W/SAFETY VENT,ELONGAT 1059 manufactured by Teleflex Medical.
[68216273]
(b)(4). A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device was not returned at the time of this report. A picture of the defect was not provided. A device history record review shows that the device was assembled and inspected according to our specifications. Customer complaint cannot be confirmed based only on the information provided. In order to perform a proper investigation, and determine the source of the alleged defect reported, it is necessary to evaluate the sample involved on this complaint. If the device sample becomes available this investigation will be updated with the evaluation results.
Patient Sequence No: 1, Text Type: N, H10
[68216274]
Customer complaint alleges that the reservoir bag did not inflate during use. A new unit was used. No report of patient harm. Patient condition was reported as "fine".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2017-00076 |
| MDR Report Key | 6354340 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-02-23 |
| Date of Report | 2017-02-13 |
| Date of Event | 2017-02-07 |
| Date Mfgr Received | 2017-02-13 |
| Device Manufacturer Date | 2016-03-09 |
| Date Added to Maude | 2017-02-23 |
| 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 | LINDA WOODALL |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9196942566 |
| 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 MASK,NON-REBREATH W/SAFETY VENT,ELONGAT |
| Generic Name | MASK, OXYGEN, NON-REBREATHER |
| Product Code | KGB |
| Date Received | 2017-02-23 |
| Catalog Number | 1059 |
| Lot Number | 74C1601549 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2017-02-23 |