MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-05-23 for SU MARK WATER BOTTLE manufactured by Sunmark.
[12600]
The water bottle spilt hot water all over her, causing severe burns and disfigurement. Device not labeled for single use. Patient medical status prior to event: unknown. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. Imminent hazard to public health claimed. Invalid data - whether device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: none or unknown. Results of evaluation: none or unknown. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: unknown (cannot determine). Corrective actions: none or unknown. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 32649-1995-00001 |
| MDR Report Key | 23358 |
| Date Received | 1995-05-23 |
| Date of Report | 1995-05-23 |
| Date of Event | 1995-02-03 |
| Date Facility Aware | 1995-05-08 |
| Report Date | 1995-05-23 |
| Date Reported to FDA | 1995-05-23 |
| Date Reported to Mfgr | 1995-05-16 |
| Date Added to Maude | 1995-06-29 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | UNKNOWN |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SU MARK WATER BOTTLE |
| Generic Name | NA |
| Product Code | FPF |
| Date Received | 1995-05-23 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | * |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 23633 |
| Manufacturer | SUNMARK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1995-05-23 |