MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-09 for DENTIPS MDS096011 manufactured by Productos Medline S.a. De C.v..
[141327432]
While performing routine mouth care, oral care swab/sponge separated from stick and remained in the patient's mouth. Sponge was recovered by bedside rn with 4th attempt at oral sweep.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8495069 |
| MDR Report Key | 8495069 |
| Date Received | 2019-04-09 |
| Date of Report | 2019-04-04 |
| Date of Event | 2019-03-17 |
| Report Date | 2019-04-04 |
| Date Reported to FDA | 2019-04-04 |
| Date Reported to Mfgr | 2019-04-09 |
| Date Added to Maude | 2019-04-09 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | DENTIPS |
| Generic Name | APPLICATOR, ABSORBENT TIPPED, STERILE |
| Product Code | KXG |
| Date Received | 2019-04-09 |
| Catalog Number | MDS096011 |
| Lot Number | 18-285 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRODUCTOS MEDLINE S.A. DE C.V. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-09 |