MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-03-01 for TOOTHETTE? ORAL CARE DISPOSABLE ORAL SWAB 6071 manufactured by Sage Products Llc.
[101634767]
Reporter discarded the involved product and did not provide photographs or lot information. Due to the lack of lot information, a product history record could not be reviewed. Reporter stated that some green foam remained on the swab handle. This would indicate that the foam head was glued to the swab handle appropriately. Reporter stated the patient bit down on the green foam and caused it to disengage and no bite block was used. Per packaging instructions, it states, "use a bite block when performing oral care on patients with altered levels of consciousness, or those who cannot comprehend commands. " the root cause of the reported condition could be attributed to the patient's biting of the foam head.
Patient Sequence No: 1, Text Type: N, H10
[101634768]
Report received of a foam disengagement due to biting. On (b)(6) 2018, oral care was performed on a male patient. The reporter stated the patient bit down on the green foam and the green foam disengaged from the stick. The reporter stated the patient swallowed the disengaged foam piece. The reporter stated no injury occurred to the patient or nurse who performed the oral care. The reporter did not know if the patient suffered from an altered level of consciousness or was unable to comprehend commands. The reporter stated the adverse event occurred during initial use of the product and a bite block was not in place. The reporter stated following foam disengagement, green foam pieces were evident on the oral swab stick. The device was discarded and no pictures were available. Although requested, no additional information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419181-2018-00001 |
| MDR Report Key | 7307110 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-03-01 |
| Date of Report | 2018-03-01 |
| Date of Event | 2018-02-06 |
| Date Mfgr Received | 2018-02-06 |
| Date Added to Maude | 2018-03-01 |
| 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 IL 60013 |
| Manufacturer Country | US |
| Manufacturer Postal | 60013 |
| Manufacturer Phone | 8154554700 |
| Manufacturer G1 | SAGE PRODUCTS LLC |
| Manufacturer Street | 3909 THREE OAKS ROAD |
| Manufacturer City | CARY IL 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 DISPOSABLE ORAL SWAB |
| Generic Name | ORAL SWAB |
| Product Code | KXF |
| Date Received | 2018-03-01 |
| Model Number | 6071 |
| Catalog Number | 6071 |
| Lot Number | UNKNOWN |
| Operator | NURSE |
| 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 IL 60013 US 60013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-01 |