MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-02 for CROSS PROTECTION 5-501 CB manufactured by Cross Protection M Sdn Bhd.
[90973748]
The tip of ejector fell of clear tube post endotracheal intubation into oropharynx. The device was intact prior use and was performed properly during first three oral suctions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073095 |
| MDR Report Key | 6996097 |
| Date Received | 2017-11-02 |
| Date Added to Maude | 2017-11-02 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CROSS PROTECTION |
| Generic Name | SALIVA EJECTOR |
| Product Code | DYN |
| Date Received | 2017-11-02 |
| Model Number | 5-501 CB |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CROSS PROTECTION M SDN BHD |
| Manufacturer Address | NO. 11, JALAN PERINDUSTRIAN 5, BATU 5 1/2 OFF JALAN HAJI ABDUL MANAN KLANG SE LANGOR 41050 MY 41050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-02 |