MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2004-03-05 for ALBERTSON'S DELUXE WATER BOTTLE 12415 manufactured by Abbott Laboratories.
[367404]
Report received of a water bottle that "broke' causing burns. Reportedly, in 2003 the pt filled the hot water bottle from the tap and placed it on their left knee "over my pajamas. " at an unspecified time during use, reportedly the hot water bottle broke at an unspecified area and hot water "started to leak down my leg. I thought the cap had come off, but when the paramedics came, they said it was still on. " the pt reportedly was taken by ambulance to the hosp and was referred to their physician for further evaluation and treatment. The pt required dressing changes every other day by a visiting rn and unspecified doses of vicodin for pain. Though requested, no additional info was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1520456-2004-00001 |
| MDR Report Key | 515025 |
| Report Source | 04 |
| Date Received | 2004-03-05 |
| Date of Report | 2004-02-12 |
| Date of Event | 2003-08-26 |
| Date Mfgr Received | 2004-02-12 |
| Date Added to Maude | 2004-03-11 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | THOMAS SAMPOGNA, ASSOC DIR |
| Manufacturer Street | 200 ABBOTT PARK ROAD DEPT. 389 BLDG. J-45 |
| Manufacturer City | ABBOTT PARK IL 600646132 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646132 |
| Manufacturer Phone | 8479353715 |
| Manufacturer G1 | ABBOTT LABORATORIES |
| Manufacturer Street | 268 EAST FOURTH ST |
| Manufacturer City | ASHLAND OH 44805 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44805 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | UNK |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALBERTSON'S DELUXE WATER BOTTLE |
| Generic Name | HOT WATER BOTTLE |
| Product Code | FPF |
| Date Received | 2004-03-05 |
| Returned To Mfg | 2004-02-23 |
| Model Number | NA |
| Catalog Number | 12415 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 504032 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 268 EAST FOURTH ST. ASHLAND OH 44805 US |
| Baseline Brand Name | ALBERTSON'S DELUXE WATER BOTTLE |
| Baseline Generic Name | HOT WATER BOTTLE |
| Baseline Model No | NA |
| Baseline Catalog No | 12415 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-03-05 |