MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-23 for MEDLINE SUCTION SWAB TRAY manufactured by Medline Industries Inc..
[106402317]
While performing oral care using medline oral care kit, the green sponge easily fell off the suction stick and was in the back of pt's mouth. Pt is intubated and has etad with built in bite block. Pt also sedated at this time and not biting or moving with oral care. Gentle swabbing of tongue was being performed when noticed sponge had fallen. Immediately removed green sponge from back of mouth with yankauer and assistance by rn with pen light. Full piece was removed and no other piece visible.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076663 |
| MDR Report Key | 7453820 |
| Date Received | 2018-04-23 |
| Date of Report | 2018-04-20 |
| Date of Event | 2018-04-13 |
| Date Added to Maude | 2018-04-24 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | MEDLINE SUCTION SWAB TRAY |
| Generic Name | DENTAL HYGIENE KIT |
| Product Code | NXZ |
| Date Received | 2018-04-23 |
| Lot Number | 18-043-02 |
| Device Expiration Date | 2019-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-04-23 |