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 2019-03-08 for CPAP DRUCKSCHLAUCH AS PRO 706422 manufactured by Vyaire Medical.
[138276819]
Other - a photo evaluation and interview was conducted by a vyaire medical representative. Upon further investigation, no product problem could be determined. The most likely cause of the irritation was due to the cleaning solution utilized by the user-facility for the tubing.
Patient Sequence No: 1, Text Type: N, H10
[138276820]
Initial information reported that a patient had come into the practice with "burn injuries" on the neck. He brought the t3 with which a cpap check was carried out. The pressure measuring tube ran along the patient's neck, because the connection of the mask was located on top of the head. She was informed that the device was not heated, so it could not get hot. They assume it is an allergic reaction. Further investigation revealed the tubing had rubbed the patient throughout the night, and the practice determined it was an irritation, no allergic reaction. A liquid disinfectant, instruextra (1% concentration), is used between each use. Medical intervention of ointment to the affect area was provided. A few days later, the reported was reported to be fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615102-2019-00102 |
| MDR Report Key | 8405030 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-08 |
| Date of Report | 2019-02-12 |
| Date of Event | 2019-02-08 |
| Date Mfgr Received | 2019-02-12 |
| Date Added to Maude | 2019-03-08 |
| 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 | STANLEY TAN |
| Manufacturer Street | 22745 SAVI RANCH PKWY |
| Manufacturer City | YORBA LINDA CA 92887 |
| Manufacturer Country | US |
| Manufacturer Postal | 92887 |
| Manufacturer Phone | 7149193324 |
| Manufacturer G1 | VYAIRE MEDICAL GMBH |
| Manufacturer Street | LEIBNIZSTRASSE 7 |
| Manufacturer City | HOECHBERG BAYERN, 97204 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 97204 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CPAP DRUCKSCHLAUCH AS PRO |
| Generic Name | PRESSURE MONITORING TUBING |
| Product Code | MNR |
| Date Received | 2019-03-08 |
| Catalog Number | 706422 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL |
| Manufacturer Address | 22745 SAVI RANCH PKWY YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-03-08 |