MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2002-02-28 for GOODHEALTH WATER BOTTLE 2816 manufactured by Abbott Laboratories.
[253942]
Report received from abbott ashland of two broken water bottles. The report states, "customer purchased two water bottles. Both broke, and the second time it caused a minor injury to spouse. Injury was not serious according to complainant. " additional information was requested, but at the consumer's request, no further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1520456-2002-00002 |
| MDR Report Key | 380181 |
| Report Source | 04,07 |
| Date Received | 2002-02-28 |
| Date of Report | 2002-01-29 |
| Date of Event | 2002-01-01 |
| Date Mfgr Received | 2002-01-29 |
| Date Added to Maude | 2002-03-08 |
| 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 | FRANK POKROP, ASST. DIR. |
| Manufacturer Street | 200 ABBOTT PARK ROAD DEPT. 37K BLDG. J-45 |
| Manufacturer City | ABBOTT PARK IL 600646132 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646132 |
| Manufacturer Phone | 8479378473 |
| 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 WATER BOTTLE |
| Generic Name | WATER BOTTLE |
| Product Code | FPF |
| Date Received | 2002-02-28 |
| Model Number | NA |
| Catalog Number | 2816 |
| 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 | 369227 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 268 EAST FOURTH ST. ASHLAND OH 44805 US |
| Baseline Brand Name | GOODHEALTH WATER BOTTLE |
| Baseline Generic Name | HOT WATER BOTTLE |
| Baseline Model No | NA |
| Baseline Catalog No | 2816 |
| 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. Other | 2002-02-28 |