MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-08 for 24HR, WITH HYDROGEN PEROXIDE, ORAL SUCTION MDS606804HP manufactured by Medline Industries Inc.
[107598907]
Patient Sequence No: 1, Text Type: N, H10
[107598908]
When nurses perform oral care for patients, the sponges of the green suction swabs fell off into patients' mouths. This event happened on the multiple days. Manufacturer response for oral care products, 24 hr, with hydrogen peroxide, oral suction (per site reporter): medline's product quality team did inspection on their suction swabs in the factory and added extra glue to the swab in the manufacturing process. They replaced our stock with new lots.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7494368 |
| MDR Report Key | 7494368 |
| Date Received | 2018-05-08 |
| Date of Report | 2018-05-02 |
| Date of Event | 2018-03-20 |
| Report Date | 2018-04-26 |
| Date Reported to FDA | 2018-04-26 |
| Date Reported to Mfgr | 2018-04-26 |
| Date Added to Maude | 2018-05-08 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Brand Name | 24HR, WITH HYDROGEN PEROXIDE, ORAL SUCTION |
| Generic Name | ORAL CARE PRODUCTS |
| Product Code | NXZ |
| Date Received | 2018-05-08 |
| Catalog Number | MDS606804HP |
| Lot Number | 18-039-1 |
| Operator | NURSE |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-08 |