MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-05 for TOOTHETTE PTE NON-IMPRG 800 6005 manufactured by Sage Products Llc.
[113627378]
Reporter stated that the involved product was discarded, 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. Review of the product labeling instruct the user to,? Use per hospital protocol. Ensure foam is intact after use. If not, remove any particles from oral cavity.? The root cause for the reported issue could not be determined. Based on the lack of information, no product evaluation, and review of product history records, there is insufficient evidence to conclude that the reported issue was attributable to a product defect or manufacturing operations. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[113627379]
Report received of a malfunction resulting in swab disengagement. On (b)(6) 2018, oral care was performed on a patient. Reporter stated two green foam pieces disengaged from the stick. Reporter stated the foam was successfully removed from the patient's oral cavity and no injury occurred to the patient or nurse. Reporter stated the size of the disengaged foam pieces was unknown, however, the majority of the green foam remained adhered to the swab stick. Reporter stated the patient did not bite on the device. Reporter stated it is unknown if the reported issue occurred during initial use of the product or if it was reused. The device was discarded and no photographs were available for evaluation. Although requested, no additional information was available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001419181-2018-00023 |
| MDR Report Key | 7664284 |
| Date Received | 2018-07-05 |
| Date of Report | 2018-07-05 |
| Date of Event | 2018-03-01 |
| Date Mfgr Received | 2018-06-07 |
| Device Manufacturer Date | 2017-07-24 |
| Date Added to Maude | 2018-07-05 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. 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 PTE NON-IMPRG 800 |
| Generic Name | APPLICATOR SWAB |
| Product Code | KXF |
| Date Received | 2018-07-05 |
| Model Number | 6005 |
| Catalog Number | 6005 |
| Lot Number | 62328 |
| 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 IL 60013 US 60013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-05 |