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.
[41474]
In attempting to treat lower back pain, the user filled the bottle with hot water, wrapped it in a towel, placed it in a chair, and sat down with her back against the bottle. Air leak from a hole in the bottom of the bottle and hot water spilled over user's back and rectum, producing blisters which burst. User was urgently treated by a physician.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1520456-1997-00002 |
| MDR Report Key | 70277 |
| Report Source | 04 |
| Date Received | 1997-02-14 |
| Date of Report | 1997-02-04 |
| Date of Event | 1996-12-06 |
| Date Facility Aware | 1996-12-06 |
| Report Date | 1997-02-04 |
| Date Mfgr Received | 1997-02-04 |
| 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 | 70194 |
| 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 |