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 2018-06-19 for HUDSON MASK,NON-REBREATING W/O SFTY VENT,ELONG 41060 manufactured by Teleflex Medical.
[111667652]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[111667653]
Customer complaint alleges "whist using a high concentration oxygen mask (adult size) with an oxygen bottle, the nurse reported that the balloon did not inflate". Alleged malfunction reported as occurred during a patient use. It was reported there was no consequence for the patient. The patient condition was reported as "fine".
Patient Sequence No: 1, Text Type: D, B5
[113564803]
(b)(4). Complaint verification testing could not be performed as no sample was available for analysis. Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information. Teleflex will continue to monitor and trend for reports of this nature.
Patient Sequence No: 1, Text Type: N, H10
[113564804]
Customer complaint alleges "whist using a high concentration oxygen mask (adult size) with an oxygen bottle, the nurse reported that the balloon did not inflate". Alleged malfunction reported as occurred during a patient use. It was reported there was no consequence for the patient. The patient condition was reported as "fine".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2018-00205 |
| MDR Report Key | 7615713 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-06-19 |
| Date of Report | 2018-06-01 |
| Date of Event | 2018-06-01 |
| Date Mfgr Received | 2018-06-27 |
| Date Added to Maude | 2018-06-19 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 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-REBREATING W/O SFTY VENT,ELONG |
| Generic Name | MASK, OXYGEN, NON-REBREATHING |
| Product Code | KGB |
| Date Received | 2018-06-19 |
| Catalog Number | 41060 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-06-19 |