MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2000-03-16 for GOODHEALTH PREMIUM 2814 manufactured by Abbott Laboratories.
[17491128]
Report of burn while water bottle in use. Letter, dated 3/7/00, received from customer states "upon retiring near midnight on 11/27, consumer prepared the water bottle with hot water to place on forehead to relieve sinus pressure/congestion. As consumer layed in bed, consumer placed the water bottle across forehead and then started to fall asleep. Within a few minutes, the water bottle broke open and hot water poured down the left side of consumer's face and down consumer's left shoulder and arm. Consumer experienced such severe pain from this that consumer was thrown into a state of extreme shock and consumer could hardly scream for help. Consumer's daughter came to the rescue and immediately called the emergency room of the local hospital. Hospital advised to apply cold compresses on the burned area and to call family doctor in the morning. At six o'clock the following morning, consumer called family physician, who prescribed a burn medication and gave instructions to prevent infection. Shortly thereafter, 3-inch blisters formed and covered the arm from the shoulder to the elbow. " additional info has been requested. When any significant info relevant to this incident becomes available, it will be submitted in a follow-up.
Patient Sequence No: 1, Text Type: D, B5
[17763274]
Add'l info obtained via medical records rec'd from the customer's physician. A summary of the records follows: pt with chief complaint of burn to left shoulder and upper arm. Using hot water bottle 5 days agp - broke - second degree, non-circumferential burn on left shoulder, upper arm and chest. Large surface area of upper left arm on outer surface with redness, swelling and granulation tissue somewhat tender to palpation. Most of blisters have ruptured on their own. First degree burn to left upper cheek. Clear fluid filled blister to left elbow. Still with pain at 5 on a 10 point scale. No numbness or tingling to burn area. Re-check: less pain, much less swelling, still some granulation tissue, healing great. Left arm still with erythema and scabs over blistered areas, pruritic. Also has burn to right thigh with quarter sized area of erythema with good granulation tissue. Overall much improved. Swelling persists but much less so. No further pain, overall better. Left upper arm with few scabs and post-inflammatory hyperpigmentation, good pulses. Re-check as needed. There were no further visits indicated in the records rec'd.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1520456-2000-00002 |
| MDR Report Key | 270130 |
| Report Source | 04 |
| Date Received | 2000-03-16 |
| Date of Report | 1999-12-01 |
| Date of Event | 1999-11-28 |
| Date Mfgr Received | 1999-12-01 |
| Date Added to Maude | 2000-03-22 |
| 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 | JILL SACKETT, DIRECTOR |
| Manufacturer Street | 200 ABBOTT PARK RD DEPARTMENT 389,AP30 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GOODHEALTH PREMIUM |
| Generic Name | WATER BOTTLE |
| Product Code | FPF |
| Date Received | 2000-03-16 |
| Returned To Mfg | 2000-03-10 |
| Model Number | NA |
| Catalog Number | 2814 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 261520 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 268 EAST FOURTH ST. ASHLAND OH 44805 US |
| Baseline Brand Name | GOODHEALTH PREMIUM |
| Baseline Generic Name | HOT WATER BOTTLE |
| Baseline Model No | NA |
| Baseline Catalog No | 2814 |
| Baseline Device Family | BOTTLE, HOT/COLD WATER |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-03-16 |