MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-12-14 for TOOTHETTE? ORAL CARE DISPOSABLE ORAL SWAB 6075 manufactured by Sage Products Llc.
[95072594]
Reporter discarded the involved product and did not provide photographs or lot information. Production history records could not be reviewed. The root cause for the reported issue could not be determined. Based on the lack of information and product for evaluation, there is insufficient evidence to conclude that the reported issue was attributable to a product defect or manufacturing operations.
Patient Sequence No: 1, Text Type: N, H10
[95072596]
Report received of a malfunction resulting in an applicator swab disengagement. On (b)(6) 2017, the reporter stated the device was removed from its individual packaging and dipped into a cup of water. Reporter stated small green foam pieces disengaged from the device and were found floating in the cup of water. The reporter stated the device was not used and no injury occurred. The device was discarded and no photographs or lot information was available. Although requested, no additional information was available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419181-2017-00010 |
| MDR Report Key | 7119446 |
| Report Source | CONSUMER |
| Date Received | 2017-12-14 |
| Date of Report | 2017-12-14 |
| Date of Event | 2017-11-29 |
| Date Mfgr Received | 2017-11-30 |
| Date Added to Maude | 2017-12-14 |
| 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 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| 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 | 2017-12-14 |
| Model Number | 6075 |
| Catalog Number | 6075 |
| Lot Number | UNKNOWN |
| 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 | 2017-12-14 |