MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2004-03-15 for GOODHEALTH BOTTLE (HOT WATER BOTTLE) 02816 manufactured by Abbott Laboratories.
[357517]
Report rec'd of a water bottle that leaked while in use. The consumer reported that they placed the water bottle on their back. Pt then noted that it had "gotten their bed all wet. " the consumer reported that the leak was from the "plug" of the device. There were no reported adverse pt effects and no medical interventions were required. Though requested, no add'l info was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1520456-2004-00002 |
| MDR Report Key | 534371 |
| Report Source | 04 |
| Date Received | 2004-03-15 |
| Date of Report | 2004-02-20 |
| Date of Event | 2004-02-01 |
| Date Mfgr Received | 2004-02-20 |
| Date Added to Maude | 2004-07-16 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | THOMAS SAMPOGNA, ASSOC DIRECTOR |
| 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 | 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 | 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 | 2004-03-15 |
| 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 | 523639 |
| 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. Other | 2004-03-15 |