MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-06-29 for MDS606902HP manufactured by Medline Industries Inc..
[112789175]
It was reported that the sponge fell of the tip of an oral care swab and into a patient's mouth. It was not identified at what point during oral care this incident occurred. Reportedly, the sponge was not able to be retrieved. After multiple good-faith attempts, the facility reported that they are unable or unwilling to provide additional patient, product, or procedural information related to this incident. No impact to the patient, the patient's stability, the patient's plan of care, or to the procedure was originally reported. No samples were available to be returned to the manufacturer for evaluation. Due to the reported incident, and in an abundance of caution, this medwatch is being filed. If additional relevant information becomes available a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[112789176]
It was reported that the sponge fell of the tip of an oral care swab and into a patient's mouth. Reportedly, the sponge was not able to be retrieved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2018-00063 |
| MDR Report Key | 7651687 |
| Report Source | USER FACILITY |
| Date Received | 2018-06-29 |
| Date of Report | 2018-06-29 |
| Date of Event | 2018-05-31 |
| Date Mfgr Received | 2018-06-12 |
| Date Added to Maude | 2018-06-29 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NIGEL VILCHES |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 600932753 |
| Manufacturer Country | US |
| Manufacturer Postal | 600932753 |
| Manufacturer Phone | 2249311458 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | 24HR, ORAL SUCTION KIT, CHG, HP, 2HR |
| Product Code | NXZ |
| Date Received | 2018-06-29 |
| Catalog Number | MDS606902HP |
| Operator | NURSE |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 600932753 US 600932753 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-06-29 |