MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-01-24 for HOLMES HM5082 manufactured by Sunbeam Products, Inc..
[176259377]
There is an instruction that states, "never place humidifier in an area where it is accessible to children" and consumer failed to perform that instruction.
Patient Sequence No: 1, Text Type: N, H10
[176259378]
The consumer filed an incident report with the cpsc reference number (b)(4) alleging that a humidifier caused personal injury to their daughter after falling on the unit from her bed. There was not a report of property damage with this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003862163-2020-00007 |
| MDR Report Key | 9627565 |
| Report Source | OTHER |
| Date Received | 2020-01-24 |
| Date of Report | 2020-01-24 |
| Date of Event | 2019-12-24 |
| Date Added to Maude | 2020-01-24 |
| 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 | MICHAEL MILES |
| Manufacturer Street | 303 NELSON AVE. |
| Manufacturer City | NEOSHO MO 64850 |
| Manufacturer Country | US |
| Manufacturer Postal | 64850 |
| Manufacturer Phone | 4174557441 |
| Manufacturer G1 | DONGGUAN HUIXAN ELECTRICAL PRODUCTS CO. |
| Manufacturer Street | NO. 9112, HUNG YEH 8TH ROAD |
| Manufacturer City | TANGXIA TOWN, |
| Manufacturer Country | CH |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOLMES |
| Generic Name | HUMIDIFIER |
| Product Code | KFZ |
| Date Received | 2020-01-24 |
| Model Number | HM5082 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUNBEAM PRODUCTS, INC. |
| Manufacturer Address | 2381 EXECUTIVE CENTER DR. BOCA RATON FL 33431 US 33431 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-24 |