MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-06-14 for MDS606904HP manufactured by Medline Industries Inc..
[111025784]
It was reported that patient required laryngoscopy to retrieve green foam that fell from suction swab while patient was receiving oral care. Per report, the nurse and respiratory therapist who was giving oral care to the patient did not encounter any difficulties with the patient since the patient did not bite down on the green foam at the tip of the suction swab. It was not identified whether patient was intubated or whether an artificial airway was in place at the time of the incident. It was reported that the patient required laryngoscopy to visualize and successfully retrieve the detached green foam from the suction swab. The patient is reportedly doing well and is stable at this time. Due to the reported required medical intervention, this medwatch is being filed. The sample was not returned for evaluation. A root cause could not be identified at this time. If additional relevant information becomes available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[111025785]
It was reported that patient required laryngoscopy to retrieve green foam that fell from suction swab.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2018-00059 |
| MDR Report Key | 7600710 |
| Report Source | USER FACILITY |
| Date Received | 2018-06-14 |
| Date of Report | 2018-06-14 |
| Date of Event | 2018-04-13 |
| Date Mfgr Received | 2018-05-17 |
| Date Added to Maude | 2018-06-14 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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, CHG, HP, 4HR |
| Product Code | NXZ |
| Date Received | 2018-06-14 |
| Catalog Number | MDS606904HP |
| Lot Number | 18-043-02 |
| 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 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-06-14 |