MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2017-02-03 for ORAL CARE KIT,W/MOIST,PEROXIDE 12260 991096883 manufactured by Halyard Health.
[66559515]
The actual complaint product was not returned for evaluation. A review of the device history record is not possible as no lot number was provided. Root cause could not be determined. 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. This product incident is documented in the halyard health complaint database and identified as (b)(4). Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[66559516]
Halyard received a single report that referenced an unknown number of incidences, which were associated with separate units, involving an unknown number of patients. Due to the unknown number of incidences, two reports will be submitted. This is the second of two reports. Refer to 8030647-2017-00005 for the first event. It was reported that a distributor experienced an unspecified number of oral swab sticks that broke during use. There was no known patient injury. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030647-2017-00012 |
| MDR Report Key | 6301771 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2017-02-03 |
| Date of Report | 2017-01-09 |
| Date Mfgr Received | 2017-01-09 |
| Date Added to Maude | 2017-02-03 |
| 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 | 3 |
| Brand Name | ORAL CARE KIT,W/MOIST,PEROXIDE |
| Generic Name | VAP ORAL CARE PRODUCTS |
| Product Code | KXF |
| Date Received | 2017-02-03 |
| Model Number | 12260 |
| Catalog Number | 991096883 |
| Lot Number | UNKNOWN |
| Device Availability | N |
| 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 | 2017-02-03 |