MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-17 for TOOTHETTE? ORAL CARE UNTREATED DISPOSABLE ORAL SWAB 6070-X manufactured by Sage Products Llc.
[68087930]
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. No anomalies were identified during production of the product. The root cause could not be determined. Potential root causes could be insufficient amount of glue delivered or inadequate glue adhesion during the production of the device. (b)(4); method: no testing methods performed; results: no results available since no evaluation performed; conclusion: device discarded by user, unable to follow-up. Discarded by user.
Patient Sequence No: 1, Text Type: N, H10
[68087931]
Report received of a malfunction resulting in an applicator swab disengagement. On an unknown date, oral care was performed on a female patient. The reporter stated the green foam disengaged from the stick. The reporter stated the foam was successfully removed from the patient's oral cavity and no injury occurred. The reporter stated the patient did not bite on the device. 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 | 1419181-2017-00001 |
| MDR Report Key | 6341103 |
| Date Received | 2017-02-17 |
| Date of Report | 2017-02-15 |
| Date Mfgr Received | 2017-01-18 |
| Device Manufacturer Date | 2015-09-27 |
| Date Added to Maude | 2017-02-17 |
| 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 | 0 |
| Brand Name | TOOTHETTE? ORAL CARE UNTREATED DISPOSABLE ORAL SWAB |
| Generic Name | APPLICATOR SWAB |
| Product Code | KXF |
| Date Received | 2017-02-17 |
| Model Number | 6070-X |
| Catalog Number | 6070-X |
| Lot Number | 51557 |
| Device Expiration Date | 2017-09-26 |
| Operator | PATIENT FAMILY MEMBER OR FRIEND |
| 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 | 2017-02-17 |