MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,distributor report with the FDA on 2017-06-27 for DENTASWAB,W/DENTIFRICE,20PACK 2 DISPENSER 12249 991096876 manufactured by Halyard Health.
[78495813]
The actual complaint product is available but has not been 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. All information reasonably known as of (b)(6) 2017 has been included in this health authority report. Should additional information be obtained, a follow-up health authority report will be provided. The information provided by halyard health represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to halyard health. 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 complaint (b)(4). Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[78495814]
It was reported by the distributor that the oral swab was swallowed by a patient. Additional information was reported on (b)(6) 2017 in an email from the customer on (b)(6) 2017 that the patient passed away with no other information and unknown what caused the death. Additional information was requested but none received.
Patient Sequence No: 1, Text Type: D, B5
[86729423]
All information reasonably known as of (b)(6) 2017 has been included in this health authority report. Should additional information be obtained, a follow-up health authority report will be provided. The information provided by halyard health represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to halyard health. 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 complaint (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[86729424]
Additional information was received that states, the family provided no additional details regarding the cause of death of the patient. No response from additional follow up was received. No additional information is available at this time.
Patient Sequence No: 1, Text Type: D, B5
[105947923]
All information reasonably known as of (b)(6) 2017 has been included in this health authority report. Should additional information be obtained, a follow-up health authority report will be provided. The information provided by halyard health represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to (b)(6) health. (b)(6) 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 complaint (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[105947924]
Additional information was received on (b)(6) 2017 that states, "per conversation with the patients daughter: the patient was terminally ill and being placed on hospice for late stage parkinson's, alzheimer's, and infection. The patient's daughter had requested the nursing staff not to use oral care in the patient's mouth but they did and the patient (not on ventilator) bit down and broke off the end of the oral care swab and swallowed it. There was no immediate impact on the patient due to swallowing the end of the swab and no reported respiratory consequences. The patient did die a few days later but not unexpectedly due to underlying health issues. " no additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030647-2017-00060 |
| MDR Report Key | 6670670 |
| Report Source | CONSUMER,DISTRIBUTOR |
| Date Received | 2017-06-27 |
| Date of Report | 2017-10-24 |
| Date of Event | 2017-06-03 |
| Date Mfgr Received | 2017-10-24 |
| Date Added to Maude | 2017-06-27 |
| 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 R.L. DE C.V. |
| Manufacturer Street | CARRETERA INTERNACIONAL SALIDA NORTE NO. 1053 |
| Manufacturer City | MAGDALENA, CP |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DENTASWAB,W/DENTIFRICE,20PACK 2 DISPENSER |
| Generic Name | VAP ORAL CARE PRODUCTS |
| Product Code | KXF |
| Date Received | 2017-06-27 |
| Model Number | 12249 |
| Catalog Number | 991096876 |
| Lot Number | UNKNOWN |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 1. Death | 2017-06-27 |