MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 1997-02-14 for HOT WATER BOTTLE UNK 02816 manufactured by Abbott Laboratories.
[48183]
The hot water bottle broke causing a second degree burn 12 to 14 inches in length on the left side of the body (hip area). The user was treated with analgesics, silvadene cream, and dry dressings, with good response.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1520456-1997-00001 |
| MDR Report Key | 70302 |
| Report Source | 04 |
| Date Received | 1997-02-14 |
| Date of Report | 1997-01-07 |
| Date of Event | 1996-12-10 |
| Date Facility Aware | 1996-12-10 |
| Report Date | 1997-01-07 |
| Date Mfgr Received | 1997-01-07 |
| Date Added to Maude | 1997-02-24 |
| 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 | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOT WATER BOTTLE |
| Generic Name | WATER BOTTLE |
| Product Code | FPF |
| Date Received | 1997-02-14 |
| Model Number | UNK |
| Catalog Number | 02816 |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 70218 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 268 EAST 4TH 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 | 1997-02-14 |