MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,04 report with the FDA on 2000-02-18 for OSCO DELUXE WATER BOTTLE 06775 manufactured by Abbott Laboratories.
[150596]
Report of hot water bottle splitting open rec'd. Letter rec'd from lawyer for consumer which states that a customer sustained severe burns with residual disfiguring scarring when the water bottle leaked when it split open. Legal action pending, therefore no further info is available at this time. If any further info becomes available, it will be forwarded to the agency.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1520456-2000-00001 |
| MDR Report Key | 264564 |
| Report Source | 00,04 |
| Date Received | 2000-02-18 |
| Date of Report | 2000-01-18 |
| Date of Event | 1998-02-16 |
| Date Mfgr Received | 2000-01-18 |
| Date Added to Maude | 2000-02-25 |
| 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 |
| Reporter Occupation | ATTORNEY |
| 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 380,AP30 |
| Manufacturer City | ABBOTT PARK IL 600646157 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646157 |
| Manufacturer Phone | 8479374085 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OSCO DELUXE WATER BOTTLE |
| Generic Name | HOT WATER BOTTLE |
| Product Code | FPF |
| Date Received | 2000-02-18 |
| Model Number | NA |
| Catalog Number | 06775 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 256118 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 268 EAST FOURTH ST. ASHLAND OH 44805 US |
| Baseline Brand Name | OSCO DELUXE WATER BOTTLE |
| Baseline Generic Name | HOT WATER BOTTLE |
| Baseline Model No | NA |
| Baseline Catalog No | 06775 |
| 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 | 2000-02-18 |