MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 1997-03-14 for GOODHEALTH WATER BOTTLE 00000 manufactured by Abbott Laboratories.
[19551585]
Pt purchased the hot water bottle which leaked around the neck only a short time after purchase causing burns on the pt's torso. There was no report of adverse sequelae.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1520456-1997-00003 |
| MDR Report Key | 77299 |
| Report Source | 04 |
| Date Received | 1997-03-14 |
| Date of Report | 1997-02-04 |
| Date Facility Aware | 1997-02-04 |
| Report Date | 1997-02-04 |
| Date Reported to Mfgr | 1997-02-04 |
| Date Mfgr Received | 1997-02-04 |
| Date Added to Maude | 1997-03-21 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GOODHEALTH WATER BOTTLE |
| Generic Name | HOT WATER BOTTLE |
| Product Code | FPF |
| Date Received | 1997-03-14 |
| Model Number | NA |
| Catalog Number | 00000 |
| Lot Number | 00-000-DD |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 77012 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 268 EAST FOURTH ST ASHLAND OH 44805 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-03-14 |