MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-05 for SAGE ORAL HYGIENE PRODUCTS 6512 manufactured by Sage Products.
[42335918]
While oral care was being rendered to the patient using a toothette suction swab, the patient bit down on the plastic part of the toothette and broke it in half, retaining that piece in his mouth. Numerous, various attempts to remove the (3. 5 cm) distal end of the toothette were unsuccessful. The patient had increased dyspnea and a moist cough, but no stridor. The md examined the patient and via direct laryngoscopy visualized the sponge stick piece in the lower hypopharynx overlying the vocal cords, partially obstructing the airway. The piece was removed intact using mcgill forceps and the oropharynx was suctioned thoroughly. Cxr post-event confirmed removal of the foreign body.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5061556 |
| MDR Report Key | 5563024 |
| Date Received | 2016-04-05 |
| Date of Report | 2016-04-05 |
| Date of Event | 2016-03-21 |
| Date Added to Maude | 2016-04-08 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Brand Name | SAGE ORAL HYGIENE PRODUCTS |
| Generic Name | SAGE SUCTION/CLEANING SWAB/TOOTHETTE |
| Product Code | KXF |
| Date Received | 2016-04-05 |
| Model Number | 6512 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SAGE PRODUCTS |
| Manufacturer Address | 3909 THREE OAKS RD CARY IL 60013 US 60013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-04-05 |