MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-01 for PETITE ORAL SWABSTICK FOAM TIP UNTREATED manufactured by Sage Products Llc.
[109810780]
Patient Sequence No: 1, Text Type: N, H10
[109810781]
Toothette being used for oral care on a patient and some foam pieces broke off in the baby's mouth. Product being used on a (b)(6) infant and when the toothette was being removed, a piece of the foam came apart and was noted in the oral cavity. The nurse removed the pieces and checked to ensure there were no more pieces in the mouth. Every kind of number available on the package in the incident report already. Not clinical equipment - disposable product. Sage products.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7560627 |
| MDR Report Key | 7560627 |
| Date Received | 2018-06-01 |
| Date of Report | 2018-05-24 |
| Date of Event | 2018-03-09 |
| Report Date | 2018-05-24 |
| Date Reported to FDA | 2018-05-24 |
| Date Reported to Mfgr | 2018-05-24 |
| Date Added to Maude | 2018-06-01 |
| 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 |
| 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 | PETITE ORAL SWABSTICK FOAM TIP UNTREATED |
| Generic Name | APPLICATOR, ABSORBENT TIPPED, NON-STERILE |
| Product Code | KXF |
| Date Received | 2018-06-01 |
| Lot Number | 62328 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SAGE PRODUCTS LLC |
| Manufacturer Address | 3909 3 OAKS ROAD CARY IL 60013 US 60013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-01 |