MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,04 report with the FDA on 2002-05-29 for GOODHEALTH BOTTLE (HOT WATER BOTTLE) 02816 manufactured by Abbott Laboratories.
[320279]
Additional info received. The following treatment was prescribed by the physician: slivedene ointment and vigilon dressing to right buttock vigilon dressing to right forearm keflex 500 mg twice a day x 10 days mederma cream twice a day silicone gel sheeting
Patient Sequence No: 1, Text Type: D, B5
[21634286]
Report received of a water bottle that burst causing second degree burns. The consumer sent a letter stating, "consumer is enclosing a medical release form for themselves for a physician who is treating burns/wounds from the defective water bottle consumer used from company. In 2002, used the water bottle on the side of their hip for one or two seconds, consumer held it to their right side, standing up and it burst on their right hip and right arm from wrist to elbow. According to the dr who is treating pt's wounds, consumer has second degree burns with scarring. Consumer continue to see the dr on a weekly basis". Additional info has been requested but is not presently available. Further info will be submitted in a follow-up report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1520456-2002-00003 |
| MDR Report Key | 397034 |
| Report Source | 00,04 |
| Date Received | 2002-05-29 |
| Date of Report | 2002-04-30 |
| Date of Event | 2002-04-01 |
| Date Mfgr Received | 2002-04-30 |
| Date Added to Maude | 2002-06-03 |
| 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 | THOMAS SAMPOGNA ASSOCIATE DIRECT |
| Manufacturer Street | 200 ABBOTT PARK RD DEPT. 389 BLDG. J-45 |
| Manufacturer City | ABBOTT PARK IL 600646132 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646132 |
| Manufacturer Phone | 8479353715 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| 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 | 2002-05-29 |
| Model Number | NA |
| Catalog Number | 02816 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 386082 |
| 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 | 1. Required No Informationntervention | 2002-05-29 |