MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-09-21 for CARA WATER BOTTLE COMBINATION UNK manufactured by Cara, Inc..
[20191386]
New bottle opened and the smell of rubber was so strong that the user felt the need to wash it first. User washed it with warm water and then filled it with hot water. Within a short time the user was so overcome by the smell that they had to get the bottle out of the room. The residual smell on the user's hands and bed sheets was also so strong they had to wash their clothes/sheets and hands. The user called the mfr, who replaced the bottle. When the user opened the new package they noted that the smell was still quite potent but not as potent as the previous bottle. The user plans to replace the bottle with a different brand but questions whether it is a device problem or perhaps an allergy they have developed. They report never having had breathing difficulties such as this before.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1019518 |
| MDR Report Key | 297133 |
| Date Received | 2000-09-21 |
| Date of Report | 2000-09-21 |
| Date of Event | 2000-09-19 |
| Date Added to Maude | 2000-09-25 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARA WATER BOTTLE COMBINATION |
| Generic Name | RUBBER HOT WATER BOTTLE |
| Product Code | FPF |
| Date Received | 2000-09-21 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | 3805600003 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 287612 |
| Manufacturer | CARA, INC. |
| Manufacturer Address | 255 WARWICK INDUSTRIAL DR. WARWICK RI 02886 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-09-21 |