MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-08-25 for FAULTLESS DELUXE WATER BOTTLE 2814 manufactured by Ross Laboratories.
[539]
A hot water bottle purchased by resident's family and used on resident's knee per resident request, was involved in this incident. The hot water bottles were applied to the knee on july 15, 1992. When removed, blistered areas were noted. These areas ultimately required acute care hospitalization and debridmentdevice not labeled for single use. Patient medical status prior to event: fair condition. 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. No imminent hazard to public health claimed. Device used as labeled/intended. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device permanently removed from service, other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1164 |
| MDR Report Key | 1164 |
| Date Received | 1992-08-25 |
| Date of Report | 1992-08-03 |
| Date of Event | 1992-07-15 |
| Report Date | 1992-08-03 |
| Date Reported to FDA | 1992-08-03 |
| Date Added to Maude | 1992-09-01 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FAULTLESS DELUXE WATER BOTTLE |
| Product Code | FPF |
| Date Received | 1992-08-25 |
| Model Number | 2814 |
| ID Number | 53 235 EDOO AND 43 229 ED |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Age | 01-JUL-92 |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 1112 |
| Manufacturer | ROSS LABORATORIES |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1992-08-25 |