MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-11 for SPA COMFORTS manufactured by Spa Comforts / Dream Time, Inc..
[36105065]
A new hot water bottle failed 10 minutes into use and severely burned our (b)(6) y/o daughter on her thigh and ankle. Bottle was filed 3/4 of way up with hot kettle water. Failure appears to not be along a seam but at the bottom edge 1 inch rupture and apparent weakening of the rubber in many places. (b)(6). Purchase date: (b)(6) 2015, this date is estimate. The product was not modified before the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5059318 |
| MDR Report Key | 5366192 |
| Date Received | 2016-01-11 |
| Date of Report | 2015-12-24 |
| Date of Event | 2015-12-23 |
| Date Added to Maude | 2016-01-14 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SPA COMFORTS |
| Generic Name | SPA GIRL HOT WATER BOTTLE WITH MICROFIBER CARER-LIGHT BLUE RUBBER CONSTRUCTION, |
| Product Code | FPF |
| Date Received | 2016-01-11 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPA COMFORTS / DREAM TIME, INC. |
| Manufacturer Address | SANTA CRUZ CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-11 |