MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-05-02 for MDS606802HP manufactured by Medline Industries Inc..
[107110717]
It was reported that the reporting facility was unable to find the green foam that detached from the oral swab and fell into patient's mouth. Per report, the patient did not have teeth and did not bite down while the oral care swab was used. No additional information was provided by the reporting facility at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details. The sample was not available to be returned for evaluation. Due to the reported incident and in an abundance of caution, this medwatch is being filed. No additional information was provided. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[107110718]
It was reported that the reporting facility was unable to find the green foam that detached from the oral swab and fell into patient's mouth.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2018-00034 |
| MDR Report Key | 7479530 |
| Report Source | USER FACILITY |
| Date Received | 2018-05-02 |
| Date of Report | 2018-05-10 |
| Date of Event | 2018-03-23 |
| Date Mfgr Received | 2018-04-05 |
| Date Added to Maude | 2018-05-02 |
| 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 | BERMON PUNZALAN |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Manufacturer Phone | 2249311514 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | 24HR, ORAL SUCTION KIT, HP, 2HR. |
| Product Code | NXZ |
| Date Received | 2018-05-02 |
| Returned To Mfg | 2018-05-01 |
| Catalog Number | MDS606802HP |
| Lot Number | UNK |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 1. Other | 2018-05-02 |