MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-05-28 for GOODHEALTH BOTTLE (HOT WATER BOTTLE) 02816 manufactured by Abbott Laboratories.
[156374]
Report received of breakage resulting in burn while using a water bottle. Received info from a customer stating that the water bottle was purchased in 12/98. After 2 months of use, "the hot water bottle broke resulting in me burning my stomach and injuring myself. " no further info has become available. Any additional info will be forwarded to the agency if it becomes available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1520456-1999-00002 |
| MDR Report Key | 226096 |
| Date Received | 1999-05-28 |
| Date of Report | 1999-04-28 |
| Date of Event | 1999-02-01 |
| Date Mfgr Received | 1999-04-28 |
| Date Added to Maude | 1999-06-10 |
| 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 | 0 |
| Manufacturer Contact | NANCY CONWAY, DIR REGULATORY AF |
| Manufacturer Street | 200 ABBOTT PARK RD. |
| Manufacturer City | ABBOTT PARK IL 600646157 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646157 |
| Manufacturer Phone | 8479350595 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GOODHEALTH BOTTLE (HOT WATER BOTTLE) |
| Generic Name | HOT WATER BOTTLE |
| Product Code | FPF |
| Date Received | 1999-05-28 |
| Model Number | NA |
| Catalog Number | 02816 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 219249 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 268 EAST FOURTH ST. ASHLAND OH 44805 US |
| Baseline Brand Name | GOODHEALTH BOTTLE |
| Baseline Generic Name | HOT WATER BOTTLE |
| Baseline Model No | NA |
| Baseline Catalog No | 02816 |
| Baseline ID | NA |
| Baseline Device Family | BOTTLE, HOT/COLD WATER |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-05-28 |