MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-22 for ORAL CARE KIT SUCTION SWAB manufactured by Medline.
[109160942]
Rrt was performing oral care and the oral care swab came off in patient's mouth. No harm to patient noted. The rrt states, it appeared the glue did not stick. Removed green sponge by swiping it out of mouth. Strength: chg 0. 12 percent oral rinse unk - unknown. Dose or amount: 1 unk - unknown. Frequency: 4 times a day. Route: oral. Therapy start date: (b)(6) 2018. Therapy end date: (b)(6) 2018. Diagnosis or reason for use: to prevent pneumonia in a ventilated patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077404 |
| MDR Report Key | 7536868 |
| Date Received | 2018-05-22 |
| Date of Report | 2018-05-18 |
| Date of Event | 2018-05-15 |
| Date Added to Maude | 2018-05-23 |
| 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 | PATIENT |
| 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 | ORAL CARE KIT SUCTION SWAB |
| Generic Name | ORAL CARE KIT SUCTION SWAB |
| Product Code | NXZ |
| Date Received | 2018-05-22 |
| Lot Number | 18-036-1 |
| Device Expiration Date | 2019-08-30 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-22 |