MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-31 for ORAL CARE KIT,W/MOIST,PEROXIDE 12260 991096883 manufactured by Halyard Health.
[66453314]
The actual complaint product was not returned for evaluation. The device history record for the reported lot number, m6228a601, was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance. Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[66453315]
A single report was received that referenced six different incidences, which were associated with separate units, involving six different events. This is the sixth of six reports. Refer to 8030647-2017-00006 for the first event. Refer to 8030647-2017-00007 for the second event. Refer to 8030647-2017-00008 for the third event. Refer to 8030647-2017-00009 for the fourth event. Refer to 8030647-2017-00010 for the fifth event. It was reported that the oral swab sticks were breaking during use in patient's mouth's. Additional information was received on 07-jan-2017 stated, the customer had another broken swab that broke while in use with a patient which. This additional information brought the total number to six events. No injury reported. No additional information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030647-2017-00014 |
| MDR Report Key | 6291378 |
| Date Received | 2017-01-31 |
| Date of Report | 2017-01-07 |
| Date of Event | 2016-12-30 |
| Date Mfgr Received | 2017-01-07 |
| Device Manufacturer Date | 2016-08-15 |
| Date Added to Maude | 2017-01-31 |
| 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. LISA CLARK |
| Manufacturer Street | 5405 WINDWARD PARKWAY |
| Manufacturer City | ALPHARETTA GA 30004 |
| Manufacturer Country | US |
| Manufacturer Postal | 30004 |
| Manufacturer Phone | 4704485444 |
| Manufacturer G1 | AVENT S DE RL DE CV |
| Manufacturer Street | CARRETERA INTERNACIONAL SALIDA NORTE NO. 1053 |
| Manufacturer City | MAGDALENA, CP 84160 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 84160 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ORAL CARE KIT,W/MOIST,PEROXIDE |
| Generic Name | VAP ORAL CARE PRODUCTS |
| Product Code | KXF |
| Date Received | 2017-01-31 |
| Model Number | 12260 |
| Catalog Number | 991096883 |
| Lot Number | M6228A601 |
| Device Expiration Date | 2018-08-15 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HALYARD HEALTH |
| Manufacturer Address | 5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-31 |