MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2017-10-24 for TOOTHETTE? ORAL CARE 6070-X manufactured by Sage Products Llc.
[90797467]
Reporter discarded the involved product and did not provide photographs, however, provided lot information. Production history records for the reported lot number were reviewed and all in-process checks indicated passing results. The root cause could not be determined. Potential root causes can be attributed to the force applied by the caregiver to the swab to remove it from the patient's mouth when a mouth spasm resulted in biting down on the stick of the swab.
Patient Sequence No: 1, Text Type: N, H10
[90797468]
Report received of foam disengagement due to biting. On (b)(6) 2017, oral care was performed on a male patient with a medical history of spastic quadriplegia caused by progressive brain disease. The reporter stated the patient bit down on the stick and the green foam disengaged from the stick after the nurse tried to pull the stick out of the patient's mouth. The reporter stated the foam was successfully removed from the patient's oral cavity and no injury occurred to the patient or nurse. The reporter stated the incident occurred during initial use of the product and the facility staff were aware the instructions for use state do not allow patient to bite down on swab. The device was discarded and no pictures were available. Although requested, no additional information was available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419181-2017-00009 |
| MDR Report Key | 6974699 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2017-10-24 |
| Date of Report | 2017-10-24 |
| Date of Event | 2017-09-25 |
| Date Mfgr Received | 2017-09-28 |
| Device Manufacturer Date | 2016-07-08 |
| Date Added to Maude | 2017-10-24 |
| 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 | MS. HEATHER SIRIANNI |
| Manufacturer Street | 3909 THREE OAKS ROAD |
| Manufacturer City | CARY 60013 |
| Manufacturer Country | US |
| Manufacturer Postal | 60013 |
| Manufacturer Phone | 8154554700 |
| Manufacturer G1 | SAGE PRODUCTS LLC |
| Manufacturer Street | 3909 THREE OAKS ROAD |
| Manufacturer City | CARY 60013 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60013 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOOTHETTE? ORAL CARE |
| Generic Name | ORAL SWAB |
| Product Code | KXF |
| Date Received | 2017-10-24 |
| Model Number | 6070-X |
| Catalog Number | 6070-X |
| Lot Number | 56078 |
| Device Expiration Date | 2018-07-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SAGE PRODUCTS LLC |
| Manufacturer Address | 3909 THREE OAKS ROAD CARY 60013 US 60013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-24 |